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Model Number 1DLMCP04
Device Problem Insufficient Information (3190)
Patient Problem Seroma (2069)
Event Date 12/23/2013
Event Type  Injury  
Event Description
It was reported to gore that the patient underwent open incisional hernia repair on (b)(6) 2006 whereby a gore® dualmesh® plus biomaterial was implanted. The complaint alleges that on (b)(6) 2013, an additional procedure occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: recurrence, mesh removal, severe and chronic pain/discomfort. Additional event specific information was. Additional event specific information was not provided.
Manufacturer Narrative
The plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (¿g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (¿g/cm3)]. Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: relevant medical information: (b)(6) 2006: (b)(6) regional medical center. (b)(6), md. History and physical. Had a hysterectomy with two cesarean sections, following which she developed an incisional hernia. This bulges out when she strains and spontaneously reduces. There is some pain around the hernia area. Abdomen soft, nontender, has large incisional hernia in midline incision. Impression: reducible incisional hernia. Prognosis: guarded. Level of care needed: outpatient surgery. Plan: repair incisional hernia with a gore-tex mesh on (b)(6) 2006. On (b)(6) 2006: (b)(6) regional medical center. (b)(6), rn. Pre-admission record. Smokes 1 pack/day for 20 years. On (b)(6) 2006: (b)(6) regional medical center. (b)(6), rn. Perioperative record. Asa 2. Preoperative diagnosis: incisional hernia. Implant: goretex mesh. Implant procedure: repair of incisional hernia using gore-tex mesh. Implant: gore® dualmesh® plus biomaterial [1dlmcp04/03941422, [ni] [not indicated]] implant date: (b)(6) 2006 (hospitalization (b)(6) 2006). On (b)(6) 2006: (b)(6) regional medical center. (b)(6), md. Operative report. Preoperative diagnosis: incisional hernia. Postoperative diagnosis: incisional hernia. Anesthesia: general anesthesia. Indication for procedure: this (b)(6) lady had 2 c-sections and hysterectomy following which she developed incisional hernia in the incision. It was decided to go ahead and repair this using a gore-tex mesh. Description of procedure: ¿with the patient under general anesthesia, the abdomen was prepped with duraprep and sterilely draped. The previous scar was excised and sent for histopathology. Skin and subcutaneous tissue were cut. The fascia was then opened up. On opening of the fascia, there were several defects in the fascia. These were opened up. The hernial sacs were excised and sent for histopathology. There were some adhesions of small bowel to the abdominal wall. These were separated. Following this, the sac was excised and sent for histopathology. Following this, the abdomen was closed with a continuous #1 loop pds. Following this, 2 flaps were then raised above the fascia. Gore-tex mesh was then placed above the fascia and sutured the fascia with 2-0 prolene. The jp drain was then placed and brought through a separate stab incision. The subcutaneous tissue was approximated with continuous sutures of 3-0 vicryl and skin was stapled shut. Instrument and sponge count were correct after the procedure. The patient withstood the procedure well. There were no complications. She was extubated in the or and made rapid postoperative recovery. ¿ on (b)(6) 2006: (b)(6) regional medical center. Implant sticker. Gore® dualmesh® plus biomaterial. Ref catalogue number: 1dlmcp04. Lot batch code: 03941422. W. L. Gore & associates. The records confirm a gore® dualmesh® plus biomaterial (1dlmcp04/03941422) was implanted during the procedure. Relevant medical information: on (b)(6) 2006: (b)(6). (b)(6), md. Pathology report. Accession #: (b)(6). Diagnosis: hernia sac, excision: benign fibroadipose tissue consistent with hernia sac. Clinical information: incisional hernia. Microscopic examination: sections show fragments of fibroadipose and fibroconnective tissue consistent with hernia sac. Negative for inflammation. Gross description: the specimen is received in zff in one part labeled ¿hernia sac¿. It consists of a tan-gray fibromembranous saccular measuring 7. 5 x 4. 4 x 0. 1 cm in the open state. One edge has attached fragment of adipose, glistening cut surface. On (b)(6) 2006: (b)(6) regional medical center. [signature illegible]. Admission history. (b)(6) surgeries: hysterectomy (b)(6) 2005. Reason for admission: hernia repair. On (b)(6) 2006: (b)(6) regional medical center. Lab. Albumin 3. 4 l (3. 9-5. 0). On (b)(6) 2006: (b)(6) regional medical center. (b)(6), rn. Nurse notes. Dr. (b)(6) here; informed of wbc 20. 3. Made patient a full admission. Patient states my white count went up to 28 when i had my hysterectomy in 2005. On (b)(6) 2006: (b)(6) regional medical center. (b)(6), md. Discharge summary. Final diagnosis: incisional hernia; repair using gortex mesh. Admitted, underwent repair of incisional hernia (b)(6). Admitted for control of pain and nausea. Post-operatively, had evidence of a low-grade temperature and white cell of 20,000. Kept for another 24 hours. Presently, tolerating diet, pain under control, minimal drainage from jackson-pratt drain. Taught how to empty drain; should measure output twice a day. Activity: not supposed to lift any weights. Follow up appointment in my office (b)(6). Come to emergency room if any problems. Discharge medications: darvocet-n 100 as needed for pain, augmentin 3 times/day. On (b)(6) 2006: (b)(6) regional medical center. (b)(6), rn. Discharge instructions. Regular diet. Empty jackson-pratt drain every 12 hours and as needed, record and take with you to see dr. (b)(6). No heavy lifting over 5 pounds, no excessive stretching or bending. Follow up on (b)(6) 2006. On (b)(6) 2013: university of (b)(6) medical center. (b)(6), md. Procedure report. Procedure: colonoscopy. Indications: hematochezia. Complications: no immediate complications. Impression: diverticulosis in the sigmoid colon. Three sessile polyps in the sigmoid colon. Removed with hot snare. The examination was otherwise normal. Recommendation: repeat colonoscopy in 3 years. Explant procedure: repair recurrent incisional hernia. Implantation 20 x 15 cm phasix mesh. Removal of gore-tex mesh. Bilateral rectus abdominis advancement flaps via posterior rectus sheath releases. Explant date: (b)(6) 2013 (hospitalization (b)(6) 2013). On (b)(6) 2013: university of (b)(6) medical center. (b)(6), md. Operative report. Preoperative diagnosis: recurrent incisional hernia. Postoperative diagnosis: recurrent incisional hernia. Assistant: salomon m. Levy, md. Anesthesia: general. Estimated blood loss: minimal. Complications: none. Indications: the patient presents with a symptomatic incisional hernia. She has a history of previous mesh. She presents today for elective repair. Operative findings: the defect after removal of mesh was 6 x 8 cm. This was repaired with a 20 x 15 cm phasix mesh in the retrorectus space. The fascia was closed primarily, both the posterior sheath and anterior sheath. A single 19-french blake drain was placed into the retrorectus space. The previous gore-tex mesh was excised and sent to pathology for histology. Description of procedure: ¿the patient was taken to the operating room, positioned on the operating table in a supine position. General endotracheal anesthesia was induced. Next, she was prepped and draped using sterile technique. A vertical midline incision was made from the umbilicus extending down to the suprapubic region. This extended through skin and subcutaneous tissue. A fluid-filled cavity was identified. This was opened. The fluid was drained and it was clear in nature. The mesh was noted to be at the bottom of this cavity. This was a ptfe mesh that was sutured in with prolene sutures. I excised this mesh with electrocautery, and the capsule of the seroma sac was also excised. Next, i dissected the hernia sac from the surrounding subcutaneous tissues. The hernia sac abutted the symphysis pubis. After removal of the previous mesh, the defect was approximately 6 x 8 cm. Next, i then dissected the retrorectus space, initially on the right side. I incised the anterior rectus sheath, entering the retrorectus space. I then dissected the retrorectus space from the rectus abdominis muscle out to the lateral border of the rectus. I extended this down to the space of retzius and inferiorly and superiorly a distance of 5 cm above the umbilicus. I then dissected the posterior rectus sheath off of the linea alba on the right side to facilitate placement of mesh at least 5 cm above the umbilicus. This allowed for advancement of the rectus abdominis muscle. Next, in a similar fashion, i dissected the left retrorectus space, entering the retrorectus space through the anterior rectus sheath. I then sharply dissected the rectus muscle from the posterior rectus sheath out to the lateral border of the rectus, which was then extended into the space of retzius. The bladder was somewhat adherent to the symphysis pubis, but after releasing these adhesions with electrocautery, the bladder then mobilized down fully. I then similarly incised the posterior rectus sheath medial to the linea alba wall and dissected this 5 cm above the umbilicus. Next, i then closed the posterior rectus sheath using a running 2-0 vicryl suture. This closed the posterior sheath superiorly where it had been opened. Additionally, there were a few defects in the posterior sheath, which were closed with figure-of-eight 2-0 vicryl sutures. The defect as mentioned was 6 x 8 cm. The space easily accommodated a 20 x 15 cm phasix mesh. The cavity was irrigated. Gloves were changed. I then sutured a 20 x 15 cm phasix mesh into the retrorectus space using six #1 pds sutures using the reverdin needle. Stitches were placed in the 4 corners of the mesh, superior midline and inferior midline. Inferior midline suture incorporated periosteum of the pubic symphysis. The mesh was in excellent location; it was appropriately tensioned. Next, i placed a retrorectus drain exiting the left side of the abdominal wall. This was anchored with a nylon suture. Next, i then irrigated. I then closed the fascia using figure-of-eight #1 pds sutures. I then excised additional seroma cavity. I then irrigated. I then closed the scarpa¿s layer using a 3-0 vicryl in an interrupted fashion, suturing this to the fascia as well to minimize seroma. I then closed the deep dermal with 3-0 vicryl and closed skin with 4-0 monocryl, dressed the wounds with mastisol and steri-strips. Instrument, needle, and sponge counts were all reported as correct. The patient tolerated the procedure well, was transferred to the recovery room in stable condition. I was present for and participated in the entire operation. ¿ on (b)(6) 2013: university of (b)(6) hospital. Implant sticker. Phasix mesh. Bard. Relevant medical information: on (b)(6) 2013: university of (b)(6) medical center. (b)(6), md. Pathology report. (b)(6). Diagnosis: mesh, removal (a): for gross diagnosis only. Specimen submitted as ¿seroma cavity¿. Excision (b): dense fibroconnective tissue with foreign material and giant cell reaction. Clinical history: preoperative diagnosis: recurrent incisional hernia. Intraoperative findings: ventral hernia. Operative procedure: open incisional/ventral recurrent hernia repair with mesh. Description of specimen: a: mesh. B: seroma cavity. Gross description: two specimens are received. Specimen a is received without fixative labeled ¿mesh¿ and consists of a 12. 1 x 8 x 0. 2 cm tan portion of mesh. The mesh fragment is ragged with some adherent cauterized tissue on one aspect. No inscriptions are identified. It is intact and for gross diagnosis only. Specimen label: a) seroma cavity. Fixation: formalin. Number of pieces: three. Shape(s): irregular. Color(s): tank pink to yellow. Consistency: rubbery. Size(s): ranging from 2 x 1. 5 x 1. 5 cm to 8 x 2. 5 x 0. 3 cm. The specimen is comprised of rubbery fibrofatty cauterized tissue. The fragments have a smooth glistening surface and an opposing fatty aspect. Cassette summary: representative sections are submitted in this report. On (b)(6) 2013: (b)(6) healthcare. (b)(6), md. Discharge summary. Recurrent incisional hernia admitted for open ventral, incisional hernia repair with mesh replacement and bilateral rectus abdominis advancement flaps via posterior rectus sheath releases. Medical history: type 2 diabetes, hypertension, hyperlipidemia, hypothyroidism, recurrent urinary tract infections, diverticulosis, arrhythmias. Surgical history: cesarean section 1986, 1993, hysterectomy 2006, cholecystectomy 2008, hernia repair with ptfe mesh onlay (b)(6) 2006. Taken on (b)(6) for open ventral incisional hernia repair with mesh replacement and bilateral rectus abdominis advancement flaps via posterior rectus sheath releases. A foley catheter and jackson-pratt drain were placed intraoperatively. Tolerated surgical procedure well without complication. After recovery, transferred to floor and home medications restarted. Continued to progress postoperatively. Postoperative day #1 foley and epidural removed without complication, bowel function returned, expressed increase in appetite, pain well-controlled with oral pain medication. Expressed some nausea on postoperative day #2, so kept to ensure she could tolerate by mouth. On day of discharge, ambulating, making adequate urine, tolerating intake without nausea or vomiting and pain well controlled on oral pain medications. Abdomen soft, appropriately tender to palpation. Surgical incision well approximated without erythema of surrounding tissue, drainage or dehiscence. Discharged home, stable. Medications: chantix, metformin. Resume regular diet. No lifting more than 5 lbs. For 42 days, move around as able. Follow up with dr. (b)(6) in 1 week. A potential relationship, if any, between the alleged injuries or complications and the gore device has not been established at this time based on available information.   it should be noted that the gore® dualmesh® plus biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence. The gore® dualmesh® plus biomaterial instructions for use also states: ¿strict aseptic techniques should be followed. If an infection develops, it should be treated aggressively. An unresolved infection may require removal of the material.
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Manufacturer (Section D)
1505 n. fourth street
flagstaff AZ 86004
Manufacturer (Section G)
3750 w. kiltie lane
flagstaff AZ 86005
Manufacturer Contact
jorja nackard
1505 n. fourth street
flagstaff, AZ 86004
MDR Report Key12694403
MDR Text Key282842514
Report Number2017233-2021-02487
Device Sequence Number1
Product Code FTL
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/28/2007
Device Model Number1DLMCP04
Device Catalogue Number1DLMCP04
Was Device Available for Evaluation? No
Date Manufacturer Received03/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/28/2005
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/25/2021 Patient Sequence Number: 1