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| Model Number |
F0404 |
| Medical Device Problem Code |
Adverse Event Without Identified Device or Use Problem (2993)
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| Health Effect - Clinical Codes |
Bacterial Infection (1735); Cellulitis (1768); Erythema (1840); Necrosis (1971); Seroma (2069); Burning Sensation (2146); Sleep Dysfunction (2517); Breast Discomfort/Pain (4504); Swelling/ Edema (4577)
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| Date of Event |
03/14/2017
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Type of Reportable Event
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Serious Injury
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Additional Manufacturer Narrative
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Hologic is submitting this report in accordance with 21.Cfr part 803.The submission is based upon the currently available information.The submission of this report does not represent a confirmation of device malfunction involving the hologic products in the event described.D4: lot and serial number of the device not provided by the complainant; therefore, the udi, expiration and manufacturing dates are not known.Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.H3: the device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported and a definitive root cause for the reported event could not be determined.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.
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Event or Problem Description
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It was reported that a patient underwent a lumpectomy on (b)(6) 2017 during which a biozorb was implanted.Patient had a prior diagnosis of left breast invasive ductal carcinoma.The patient reported that she had a hard, painful lump at the implantation site and that the patient felt that it grew larger.Patient reported that she could not sleep due to the pain.Patient reported that in (b)(6) 2018 she developed cellulitis in her breast and sepsis which got swollen, purple and red and additional pain.In march 2018 patient had a surgery to removed the biozorb, patient reports that the wound would not heal and had to be in and out of the hospital for the next three months.Patient reports that she suffered seroma, necrosis, infection and pain.In (b)(6) 2018 patient had a surgery to debride the infected area of the breast in which muscle was removed from her back to aid in her healing.She received additional care for another 3 months for her wound.No other information is available.
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Additional Manufacturer Narrative
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After additional medical review it was determined that the patient is a 39 years old premenopausal female, weight 247 pounds , bmi 40, with a history of depression, back pain, peripheral neuropathy, carpal tunnel syndrome, asthma, and antibiotic allergies noticed breast pain and a lump around august of 2016.Ultrasound guided biopsy revealed invasive ductal carcinoma with positive lymph node, er90%+, pr30%+, her2-.Stage iiic (t2n3c).Pet scan revealed mass in left breast and small satellite lesions in inferior lateral left breast with multiple metastatic lymph nodes.Diagnostic mammo sept2016 showed a 2.6x2cm lesion in left mid breast around 2-3o'clock position, with at least 2 possible satellite nodules and prominent left axillary nodes.The entire mammographic area encompassed 7.4x4.1x7.0cm.Patient had neoadjuvant chemotherapy (adriamycin & cytoxan followed by 12 weeks of taxol (b)(6) 2017) with reduction in tumor size and nodes on mammogram.On (b)(6) 2017 patient had breast radioseed placement.On (b)(6) 2017 she underwent left breast lumpectomy, with deep axillary lymphadenectomy and immediate bilateral mammoplasty for symmetry."a biozorb marker was then sutured within the lumpectomy cavity at the site of the malignancy to facilitate targeting for radiation therapy." the biozorb was 4x4cm, f0404, lot e1-150318.During the mammoplasty, the plastic surgeon noted, the surgery was done, "making sure to avoid any disruption to the biozorb surgical marker that had been secured with sutures in the lateral lumpectomy cavity¨.Pathology revealed invasive ductal carcinoma measuring 1.3cm in max dimension (indicating incomplete response to neoadjuvant therapy), dcis present, all margins were negative, with dcis 0.2cm from inferior margin, macrometastatic carcinoma in 2 lymph nodes w extracapsular extension.Er+ (90%strong), pr+( 40% moderate).Left breast pathology was benign.Final pathologic stage was ypt1xn1amx=iia.23mar2017, approximately 1 week post-op, the patient reported 7/10 pain mainly in the left axilla treated w percocet and ibuprofen.4 days later she continued to report "burning sensation under her left armpit and back of arm".The provider gave her a muscle relaxer.As her left shoulder range of motion was too limited for treatment positioning during radiation therapy, pt was first referred to physical therapy.She was then treated with whole breast plus lumpectomy boost and treatment of regional nodes) (b)(6) 20147.She then received triptorelin +/- everolimus.On (b)(6) 2017, approx 3 weeks post op, patient reported left breast is "dense and real hard" and swollen with intermittent pain in the left axilla, treated with prn flexeril and ibuprofen.Exam later that week notes "moderate swelling of left inferior breast as expected.Swelling, pain and bruising are all within expected and are improving since surgery." patient was advised to "massage area of fat necrosis of the left breast".Office visit with plastics surgeon (b)(6) 2017 notes her, ".Left breast became very swollen, firm and uncomfortable.A few days later the swelling and pain improved." breast exam at this visit was unremarkable and again advised to massage the area.Prior to radiation therapy, approximately 1 yr post op in (b)(6) 2017, her left shoulder range of motion was too limited for treatment positioning, patient was referred to physical therapy.Patient evaluation the same month documented, "left shoulder mobility deficits following a partial mastectomy with reconstruction on the left.Her symptoms have improved and she has experienced improved mobility of the left shoulder.5/10 pain level at worst with rolling over in bed, 2/10 pain level on average, 0/10 level at best with rest.Patient reports difficulty dressing and donning deodorant with the left upper extremity." follow up with rad onc approximately one week later noted she is working on shoulder range of motion, ".Which is improving as is her associated pain." after the patient completed radiation therapy, visit with plastic surgeon (b)(6) 2017 notes "mild pain left inferior breast in area of prior resection." the clinician, "reassured patient, pain in left lower outer breast may be normal due to scar tissue, prior resection and xrt" patient requested a second opinion from an oncologist.Note (b)(6) 2017 (approx 1.5yrs post op), from the oncologist reported breast and axilla pain, which "feels like a bruise and an incisional pain.Pain is ongoing since her surgery-overall improving." breast exam at this visit was unremarkable.Mammogram and u/s (b)(6) 2017 noted on left ".In the area palpable concern in the outer central left breast in the area of postsurgical changes there is an indistinct mass containing biozorb that begins the appearance of postop hematoma/seroma." and benign fat necrosis on right breast.Surgical oncology follow up (b)(6) 2017 noted a benign breast exam patient presented to the ed later that week with left sided chest pain, ".Progressive, now moderate¿worsened with exertion." exam revealed, "left breast with palpable area of fluctuance with some surrounding erythema and warmth that is tender." ct was negative for pe and noted, ".A soft tissue defect within the lateral aspect of the left breast which contains fluid density material, which measures 4.3x3.9cm.Placement of a surgical marker within the lumpectomy site.Fluid around a surgical marker at the lumpectomy site, which may represent a postsurgical seroma." cardiac markers were negative, patient was discharged to home to follow up with pcp.Visit with oncologist approximately 2 weeks later patient reported she ".Hasn't had pain since, the seroma is painful but they won't drain it." exam noted "mild erythema and edema probably related to the surgery and radiation." patient was advised to massage the area.Oncology visit (b)(6) 2018 almost 2 yrs post op, patient reports ".Breast erythema with swelling on and off", exam notes, "left breast without masses but mild erythema noted with edema." the patient presented to her oncologist stating she had felt a lump in her left breast that is hard and tender.Breast exam noted "left breast without masses but mild erythema noted with edema.She has induration at the surgical site measuring about a centimeter." the doctor ordered an ultrasound which revealed, "hyperechoic nodule of the left breast, 3:00 position, corresponding to the palpable abnormality.The finding is indeterminate for edema versus breast infection or developing neoplastic mass." on (b)(6) 2018, patient underwent u/s guided aspiration of "what appears to be" a seroma.The cytology report notes, "fibrin and scattered lymphocytes.The radiologist favors this to be a seroma.He states that the lesion totally disappeared following aspiration." patient reported pain resolved immediately after but then the fluid and pain had completely returned the next day.Her breast then became swollen, erythematous and warm w 10/10 pain, exam at this visit notes "left breast warm, slightly swollen, erythema throughout almost the entire breast except on the medical region of the left breast.Palpable mass/fluid collection/biozorb at 2:00 position with tenderness to touch.She appears to have cellulitis¿or a seroma or an infected biozorb." she was given po antibiotics.Patient presented to the ed 4 days later with continued complaints related to left breast with worsening pain.She was admitted and started on iv antibiotics.U/s while in the hospital confirmed the presence of a seroma.The patient was afebrile without signs/symptoms of sepsis noted.After 4 days of iv antibiotics without significant clinical improvement, on (b)(6) 2018, the treating clinician performed incision and drainage of the left breast with removal of the biozorb under general anesthesia.The op report notes, ".It appeared that none of the device had resorbed.The entire device was removed as it was felt that this was a foreign body and likely contributory to the patient's infection that had not been responsive to antibiotic therapy alone.The device was large measuring approximately 5-6cm in diameter and around it there was a large circumferential capsule." pathology revealed: "the specimen is designated "capsule breast" and consists of a 4.7 x 3.9 x 3.0 cm tan to tan-yellow portion of fibroadipose tissue that weighs 26.2 grams.There is a cylindrical cavity within the tissue that measures 3.3 cm in length and 2.4 cm in average diameter.The cavity is lined by smooth, tan-white, fibrous tissue.The external surface of the specimen is inked black.Cut section of the specimen reveals unremarkable fibroadipose tissue with no grossly apparent lesions." patient tolerated the procedure well with an uncomplicated immediate post operative course.She was discharged with a wound vac and home health care.On1(b)(6) 2018, approximately 2 weeks post explant patient presented to the ed with worsening left breast pain, swelling and burning with new pink watery drainage from the wound vac.She was re-admitted to the hospital for pain control and iv antibiotics.Patient had been doing well as an outpatient with wound care and pain management.On 3may2018, approximately 2 months post explant, the patient had fever and foul-smelling discharge from the wound and went to the ed.She was started on iv antibiotics and had a bedside wound debridement and admitted to the hospital.She was discharged the next day on oral antibiotics.Plastic surgeon note from 23may2018 notes, "most recently, she developed a delayed infection possibly related to biozorb device, s/p i&d 03/02/2018.The patient has subsequently had intermittent problems with infection.I feel it is unlikely the wound will heal without surgical intervention, in large part due to the large defect from the biozorb device and prior irradiation." on 1jun2018 she had left breast reconstruction, wound irrigation and debridement with latissimus dorsi flap.(doc116-118) pathology from this procedure revealed, ¿benign breast parenchyma and subcutaneous tissue with fat necrosis, fibrosis, foreign body giant cell reaction, acute and chronic inflammation and focal abscess formation." in jun of 2020, approximately 3 years post op/implant patient began pt for treatment of left arm swelling "as a result of stage iii breast cancer." patient was prescribed a compression garment and instructions on manual lymphatic drainage.Rad onc visit (doc150) (b)(6) 2021, patient reports she is "not happy" with the results of her breast surgeries but does not want plastics referral.She also reported persistent muscle spasms in the area of the lat dorsi and was referred to integrative medicine.Medical history: female, weight 247 pounds , bmi 40, with a history of depression, back pain, peripheral neuropathy, carpal tunnel syndrome, asthma, and antibiotic allergies noticed breast pain and a lump around august of 2016.A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.Udi: prior to establishment of guidelines : lot: e1-150318/ expires: 2017-08 ref: f0404 manufacturing date: march 18th 2015.
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Additional Manufacturer Narrative
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It was reported that a patient underwent a lumpectomy on (b)(6) 2017 during which a biozorb was implanted.Patient had a prior diagnosis of left breast invasive ductal carcinoma.The patient reported that she had a hard, painful lump at the implantation site and that the patient felt that it grew larger instead of absorbing.Patient reported that she could not sleep due to the pain.Patient reported that in (b)(6) 2018 she developed cellulitis in her breast and sepsis which got swollen, purple and red and additional pain.In (b)(6) 2018 patient had a surgery to remove the biozorb, patient reports that the wound would not heal and had to be in and out of the hospital for the next three months.Patient reports that she suffered seroma, necrosis, infection and pain.In (b)(6) 2018 patient had a surgery to debride the infected area of the breast in which muscle was removed from her back to aid in her healing.She received additional care for another 3 months for her wound.Emotional distress.No initial evaluation could be performed because there was no returned sample for this complaint.The sample was not returned for this complaint and there was limited patient-related information provided for this event; therefore, a thorough investigation was not able to be performed.Investigation into several of the harms reported in this complaint was performed from a clinical literature review, as well as an investigation into the design and risk of the biozorb product.The harms identified during this complaint are: scar tissue, pain, infection, seroma, device palpable, device explantation, redness/erythema, failure to resorb reported, necrosis, deformity, sleep dysfunction, delayed wound healing a review of clinical literature performed on lumpectomies and their associated complications was performed.A summary of this review concluded that, while lumpectomy is a well-established option for breast cancer treatment, it inherently carries risks of complications, most notably infections, seroma formation, chronic pain, and wound healing issues.The literature demonstrates variation in complication rates based on surgical technique, additional therapies (such as intraoperative radiation therapy (iort) or radiation), and individual patient factors, with infection rates ranging from 2% to 10% and seroma rates from 11% to 65%.Tissue damage / delayed wound healing / necrosis / scar tissue / erosion: biozorb (0.7%): tissue damage, including wound dehiscence and erosion, was reported in 0.7% of patients with the biozorb marker.In a more severe case, the biozorb device eroded into the nipple-areola complex, necessitating complete removal of the nipple-areola complex due to chronic inflammation.However, given that wound healing issues, tissue necrosis, and other damage are known complications of lumpectomy itself, some of these outcomes could be directly related to the surgical trauma and healing process rather than the device.Lumpectomy (13.1% of patients, delayed healing in 6.5%, and skin-flap necrosis in 1.1%, indicating that tissue damage): wound healing issues and tissue necrosis are common after lumpectomy, particularly in cases where large amounts of tissue are removed or additional procedures such as radiation are performed.Knowles et al.Reported wound infection in 13.1% of patients, delayed healing in 6.5%, and skin-flap necrosis in 1.1%, indicating that tissue damage can be a lumpectomy-related issue.Pain biozorb (0.9% to 1.9%): pain or discomfort was reported in 0.9% to 1.9% of patients with the biozorb marker.In one instance, discomfort occurred due to the device being sutured to the serratus muscle but did not result in removal.In another study, discomfort in 1.1% of patients led to device removal.However, given that pain is a well-known complication following lumpectomy, particularly in cases with nerve damage or radiation therapy, some of this discomfort could be attributed to the initial surgical intervention rather than the presence of the marker.Lumpectomy (25% to 60%): chronic pain is a frequent long-term complication of lumpectomy, affecting 25% to 60% of breast cancer surgery survivors.Kwee et al.Reported a pooled prevalence of 31% for neuropathic pain following bcs.The presence of post-surgical pain, particularly neuropathic pain caused by nerve damage, could be exacerbated by or misattributed to the biozorb marker in some cases.Infection: biozorb (0% to 5.6%): infection rates associated with biozorb ranged from 0% to 5.6%, with 1.9% of patients across studies experiencing infections.In some cases, infections were severe enough to necessitate device removal, with 5 out of 17 infections leading to removal in a registry study.Given that infection is a known complication of lumpectomy, it is likely that some infections reported in biozorb studies are related to the surgical trauma from the lumpectomy procedure, especially in cases involving re-excisions or extensive tissue manipulation.Lumpectomy (2% to 10%): infection is a recognized complication of lumpectomy, with rates ranging from 2% to 10%.Fernando et al.Reported an infection rate of 2.6% for traditional lumpectomy, while boniface et al.Found infection rates of 2.1% for breast-conserving surgery (bcs), rising to 4.6% for those undergoing mastectomy.Seroma biozorb (0.7% to 3.3%): seroma formation rates with biozorb ranged from 0.7% to 3.3%.Kaufman et al.(2021)4 observed that 82.8% of seromas occurred within the first three months after surgery, suggesting a link to the initial surgical procedure rather than the device itself.The overall seroma rate was 2.8%.Given that seromas frequently develop in response to the space left after lumpectomy, the seroma formation observed in biozorb studies may be more related to the lumpectomy rather than the device.Lumpectomy (up to 65%): seroma is a common complication following lumpectomy, with reported rates as high as 65% in some studies, particularly when combined with intraoperative radiotherapy (iort) or axillary procedures.Sfarad et al.Reported a 65% seroma rate following iort, suggesting that the surgical removal of tissue, not the marker itself, is the primary driver of this complication.Erythema / redness (hypersensitivity/allergic reaction/ itching sensation): claudia et al (admoun c, mayrovitz h.Choosing mastectomy vs.Lumpectomy-with-radiation: experiences of breast cancer survivors.Cureus.Oct 2021;13(10):e18433.Doi:10.7759/cureus.18433) explored the experiences of 1,606 breast cancer survivors who underwent either mastectomy or lumpectomy with radiation, focusing on safety, complications, and patient satisfaction.Of the respondents, 978 had mastectomies and 628 had lumpectomies.The study found that lumpectomy patients experienced higher rates of radiation-related side effects, with 98% reporting issues such as skin irritation, thickening, and chest wall tenderness.Sfarad et al.(sfarad hk, allweis tm.Postoperative complications following lumpectomy with intraoperative x-ray radiation therapy: a retrospective comparative study.Clin breast cancer.Apr 2024;24(3):237-242.Doi: 10.1016/j.Clbc.2023.12.005) compared complication rates in patients undergoing lumpectomy with intraoperative radiation therapy (iort), external beam radiation therapy (ebrt), or lumpectomy alone for early breast cancer.Among the patients, seroma occurred in 65% after iort, 34% after ebrt, and 11% after lumpectomy alone (p =.000).Surgical site infections were diagnosed in 23% after iort, 15% after ebrt, and 6% after lumpectomy alone (p =.013).Postoperative erythema was reported in 34% after iort, 16% after ebrt, and 6% after lumpectomy alone (p =.000).Minor complications like scar formation, edema, and chronic tenderness occurred in 55% after iort, 47% after ebrt, and 17% after lumpectomy alone (p =.000).The study concludes that iort is associated with a higher rate of complications compared to ebrt and lumpectomy alone, although most complications were minor and transient.The authors suggest that the increased complication rates may be partially due to overreporting with the introduction of a new technology.Educating physicians and patients about potential complications and their course is recommended to help manage postoperative outcomes.Deformity (physical asymmetry / disfigurement) rahimi 2022 (rahimi a, simmons a, kim dn, et al.Preliminary results of multi-institutional phase 1 dose escalation trial using single-fraction stereotactic partial breast irradiation for early-stage breast cancer.Int j radiat oncol biol phys.Mar 1, 2022;112(3):663-670.Doi: 10.1016/j.Ijrobp.2021.10.010) concluded that cosmetic outcomes were preserved, with no significant cosmetic detriment across any dose cohort, suggesting that single-fraction s-pbi does not negatively affect patients' physical appearance post-treatment.Both patient- and physician-reported cosmetic scores were consistently favorable over 12 and 24 months of follow-up.Device removal / explantation / additional intervention / treatment / scan required: biozorb (1.3%): device removal due to adverse events, including infection, fibromatosis, pain, and anxiety, occurred in 1.3% of patients).Some removals were related to discomfort or anxiety about the device, while others were associated with complications potentially tied to the lumpectomy procedure itself, such as infection or tissue damage.Lumpectomy (percentage is not applicable): although device removal is not applicable to lumpectomy, reoperations due to complications such as infections or positive margins are not uncommon in lumpectomy patients.An investigation was performed by subject matter experts (sme¿s) into several of the harms identified as being experienced by the patient related to design, risk management, and clinical factors.The results of these investigations and potential causes can be seen below; however, it is important to note that these results do not include medical input from a qualified medical professional: pain: there is a lack of migration requirements and testing to evaluate if the device can cause tissue damage due to migration.Verification of mechanical strength and simulated use is not adequate due to several opportunities related to sampling size and test methods.The crystalline proportion in the device is unknown.Crystallinity may be causing irritation and foreign body reaction considering the long period of absorption of the device.There is a lack of usability testing evaluating the user needs, so there is no assurance that the surgical methods being used for the users are adequate.There is a lack of adequate user needs to capture appropriate design inputs, and therefore there are opportunities in design outputs and v&v activities.Migration: there is a lack of migration requirements and testing to evaluate if the device can cause tissue damage due to migration.The crystalline proportion in the device is unknown.High crystallinity may be causing migration/erosion considering the long period of absorption of the device.Verification of mechanical strength and simulated use is not adequate due to several opportunities related to sampling size and test methods.There is a lack of usability testing evaluating the user needs, so there is no assurance that the surgical methods being used for the users are adequate.There is a lack of adequate user needs to capture appropriate design inputs.Based on the clinical literature review, the harms reported to be experienced by the patient in the complaint are common symptoms from surgery and lumpectomies; therefore, a confirmation of the biozorb causing the harms was not able to be done.However, based on the review of the top harms in regard to the biozorb design and risk documentation, the adverse events reported can be tracked back to a potential shared cause: lack of adequate user needs for the product.User needs define the framework for product development and lay the ground for the definition of design inputs, design outputs and later verification and validation activities.Other potential causes are related to inadequate test methods and/or the lack of evidence to support some specific product requirements.Conclusion: when comparing the safety outcomes of the biozorb marker with general lumpectomy complications, it becomes evident that some of the complications associated with biozorb may stem from the lumpectomy procedure itself.Both procedures share overlapping risks, although the biozorb device introduces additional considerations.However, it has been confirmed that the lack of defined user needs and inadequate test methods and testing evidence are potential root causes for the harms reported in this complaint.This cause will be further investigated and addressed in a capa.The risks associated with this complaint event are further described and evaluated against the product and its hazard analysis in the health risk assessment biozorb complaint analysis.Updates to the biozorb hazard analysis risk file will be monitored.Future events will be monitored and trended.Complaint confirmed: no.Device history record (dhr) review: the dhr was reviewed with the corresponding lot; however, no relevant risk factors were found in the manufacturing process.
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