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W. L. GORE & ASSOCIATES, INC. GORE-TEX® SUTURE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
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| Device Problem
Insufficient Information (3190)
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| Patient Problem
Unspecified Infection (1930)
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| Event Date 05/04/2020 |
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Event Type
Injury
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Event Description
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It was reported to gore that the patient underwent laparoscopic ventral umbilical hernia repair on (b)(6) 2013, whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2020, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: abscess, infection, chronic pain, revision.Additional event specific information was not provided.
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Manufacturer Narrative
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B7: added medical history.H10/11: added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant preoperative complaints: (b)(6) 2013: (b)(6) surgical associates.(b)(6) md.History and physical.Presents for evaluation of hernia.Onset of hernia gradual.Course constant.Described as moderate, located in umbilical area.Associated with abdominal pain.History hernia and hypertension.Past surgery neck surgery, bilateral knee, ankle surgery x 3.Family history of bleeding disorder and hypertension.Gastrointestinal abdominal pain, blood clots (states ¿legs.¿).Wt.202 lbs, bmi 29.83.Abdomen inspection reveals diastasis recti with no hernia within it with exception of a fairly good size umbilical hernia.Located at inferior portion of diastases recti.Umbilical hernia, fairly good-sized, located in background of diastases recti.Does need umbilical hernia repaired, usually done laparoscopically with larger mesh and cut to cover the area diastases recti present since increases risk of recurrent hernia.Can take mesh and cut to cover area diastases but will not eliminate completely.Any bulge in area would require abdominoplasty.Set up as outpatient.Lovenox preoperatively and several days prophylactic dose postop as had previous deep vein thrombosis following orthopedic procedures several years ago.Follow up after surgery.Implant procedure: laparoscopic repair of umbilical hernia with a 10 x 15 cm gore-tex mesh, also covering portion of diastasis recti.[implant: gore® dualmesh® plus biomaterial, 1dlmcp03/10980975, 10 x 15 cm.] implant date: (b)(6) 2013, [same day surgery].(b)(6) 2013: (b(6) health system.(b)(6) md.Operative report.Preoperative diagnosis: ventral umbilical hernia with diastasis recti.Postoperative diagnosis: ventral umbilical hernia with diastasis recti.Indication: the patient is a 48-year-old white male who presents with history of symptomatic umbilical hernia [sic] at this time.He also had some background of the diastasis recti.Therefore, we want to proceed with a laparoscopic repair with somewhat larger mesh.Procedure: ¿the patient was taken to the or, placed in the supine position.Under general anesthesia, his abdomen was prepped and draped in usual fashion.A small subcostal incision on the left, inserted the veress needle and distended the abdomen with c02 up to 15 mmhg, replaced this with an optiview trocar.Under direct camera guidance, placed two 5-mm trocars in the left mid to lower abdomen.Working through this two 5-mm ports camera in the upper port, identified the umbilical hernia.This had little bit of omentum stuck a bit and which i was able to reduce and there was definitely no hernia in the epigastric area, just some diastasis.I went ahead and selected a 10 x 15-cm gore-tex dual mesh and pretied six sutures evenly spaced around the circumference of 0 gore-tex and rolled this up inserted with the slick side toward the bowel, rough side toward the abdominal wall.So by using a gore needle passer and local anesthetic in all the sites, i brought out cach [sic] suture up to the abdominal wall.I have come through the same skin, little bit over the fascia and brought the second level of suture after we had tied this all up to the full thickness of the muscle fascia of the abdominal wall.These were all evenly spaced down around the circumference and mesh was laid out very nicely without redundancy.After that, i did use two secure straps to tack this with multiple layers of the absorbable tacks.This secured very nicely.I used local anesthesia to infiltrate the entire abdominal wall and i was able [sic] by putting some extra saline in that level.We used this to broadly instill local into the abdominal wall for postop pain relief.I had also done the same at the trocar sites before making the incision.I closed the fascia at the 10-12 trocar site with 0 vicryl suture.The 5-mm ports did not require closure.Skin was closed with staples.Sterile dressing was applied.He was taken recovery room in satisfactory condition.¿ (b)(6) 2013: (b)(6) health system.Implant sticker.Implant: gore dualmesh® plus biomaterial.Ref catalogue number: 1dlmcp03.Lot batch code: 10980975.W.L.Gore & associates.(b)(6) 2013: (b)(6).Discharge instructions.Follow up dr.(b)(6).(b)(6) 2013.Motrin for pain.Limit activity based on soreness and how you feel.Relevant medical information: (b)(6) 2020: (b)(6) md.Operative report.Procedure: removal of foreign body from abdominal wall.Preoperative diagnosis(es): probable stitch abscess.Postoperative diagnosis(es): same.Anesthesia: mac with local.Estimated blood loss: no blood loss.History: this is a 55-year-old gentleman who six years ago underwent a laparoscopic ventral hernia repair in lexington.One year ago he developed a non-healing wound in the presumptive site of a transfascial suture.He is being taken today for suture extraction.Description of procedure: ¿after discussing the risks of the procedure with the patient including bleeding, infection, scarring, continued non-healing wound, also possible extension of infection to mesh, consent was obtained.He was taken to the operating room and placed on the operating room table in supine position.After administration of iv sedation, his abdomen was sterilely prepped and draped.Local anesthetic was injected around the chronic wound in the right upper abdomen of his abdomen.The incision was extended through a probing with a hemostat and my index finger.Finally a multi-knotted gore-tex suture was found.It was cut at the fascia and removed.The wound was packed with quarter inch iodoform gauze.A dry dressing was applied.Patient was transferred to recovery room in stable condition.No apparent complications at this time.¿ explant preoperative complaints: (b)(6) 2020: (b)(6) medical center.(b)(6) md.Indications: the patient has a history of prior ventral hernia with gore-tex mesh.He has undergone incision and drainage.He presents today for removal of infected gore-tex mesh with gross purulence.Explant procedure: 1) repair of recurrent incisional hernia.2) removal of infected mesh.3) implantation of 20 x 15 cm strattice mesh.4) bilateral rectus advancement flaps by means of posterior rectus sheath releases.5) negative pressure wound therapy 12 x 4 cm and 4 x 2 cm wounds.Explant date: (b)(6) 2020 [hospitalization (b)(6) 2020.(b)(6) 2020: (b)(6) medical center.(b)(6) md.Operative report.Preoperative diagnosis: recurrent incisional hernia, infected mesh.Postoperative diagnosis: recurrent incisional hernia, infected mesh.Assistant surgeons: 1) (b)(6) md.2) (b)(6) md.Anesthesia: general.Estimated blood loss: 50 cc.Specimens: complications: none.Findings: there was a gore-tex mesh which was intraperitoneal.This was excised.Gore-tex sutures were also excised.The sinus cavity draining from the right upper quadrant was also excised.We then performed repair by means of posterior rectus sheath releases with rectus advancement flaps and implantation of a 20 cm tall x 15 cm wide strattice mesh.The defect was approximately 12 x 8 cm.Procedure: ¿the patient was taken to the operating room and positioned on the operating table in the supine position.General endotracheal anesthesia was induced.Next, he was prepped and draped using sterile technique.A vertical midline incision was made over the firm, indurated area of mesh.The sinus draining purulence was located to the right of midline.Dissection was carried down through the midline until the hernia sac and the mesh was encountered.Dissection was carried down directly to the mesh.A gore-tex mesh was palpated.I then circumferentially dissected the mesh from the peritoneum and fascia.Gore-tex sutures were encountered circumferentially holding the mesh in place.Each of these were cut and the sutures were carefully removed.Adhesions to the undersurface of the mesh were divided carefully without injury.The mesh was then removed in its entirety.I began by incising the posterior rectus sheath on the left side of the abdominal wall.I dissected through the rectus complex.I then elongated this incision on the posterior rectus sheath approximately 20 cm in length.I then dissected the posterior rectus sheath from the rectus abdominal muscle.I dissected the epigastric vessels with the rectus complex.I dissected out to the lateral border of the rectus as evidenced by the neurovascular bundles.In a similar fashion on the right side of the abdominal wall, i incised the posterior rectus sheath.This side was significantly more challenging related to the inflammatory process and the inflammatory rind of tissue from the prior mesh.I was able to identify the posterior rectus sheath and dissect through this above and below the inflammation.I was then able to identify the retrorectus space.I then elongated the incision in the posterior rectus sheath approximately 20 cm.I dissected the rectus muscle from the posterior rectus sheath.The epigastric vessels were carefully dissected with the rectus complex to preserve the neurovascular bundle, maintaining a pedicle vascularized flap.I dissected the posterior rectus sheath insertion into the linea alba both superiorly and inferiorly.Next, i copiously irrigated the wound.I cultured the wound previously by culturing gross purulence surrounding the mesh.The abscess cavity was excised in its entirety.I closed the posterior rectus sheath and peritoneum using a running maxon suture.Next, we change our gloves.We irrigated the retrorectus space copiously and assured hemostasis.We placed a 20 cm tall x 15 cm wide strattice mesh into the retrorectus space.This was anchored with #1 maxon sutures placed through the wound edges holding it in place.I placed a 19-french blake drain over the mesh and exited it in the left upper quadrant secured with a prolene suture.I closed the fascia using interrupted figure-of-eight #1 maxon sutures.The fascia closed without difficulty.Of note, prior to closing the fascia and placing the mesh, we did excise the fistula tract in the right upper quadrant.An elliptical skin incision was made surrounding the draining sinus and this was dissected circumferentially down to the level of the fascia and excised as this was a chronic draining sinus for draining purulence.I closed the anterior fascia at the site of the right upper quadrant sinus with interrupted #1 maxon sutures, burying the knots.We then elected to leave the subcutaneous tissues open and treat it with negative pressure wound therapy.A black sponge approximately 12 x 4 cm was placed in the midline and a second sponge approximately 4 x 2 cm was placed at the right upper quadrant wound.These were appropriately fashioned with the bridge between the 2 wounds.We placed the plastic dressing and the lily pad.There was excellent seal on the negative pressure wound therapy.The patient tolerated the procedure well.There were no immediate complications.I was present for and participates in the entire operation.¿ (b)(6) 2020: (b)(6) hospital.(b)(6) rn.Implant record.Stratticetm.Lot: sp200232-235.Ref: (b)(4).Exp: (b)(6) 2022.Size (cm): 20x20 firm.Lifecell corp.(b)(6) 2020: (b)(6) health care.[physician name was not provided.] microbiology report.Specimen: hardware mesh transport swab(s).Quantitation: light growth.Culture: 1+ biotype 1 staphylococcus aureus.1+ biotype 2 staphylococcus aureus.Gram stain: ¿improper specimen for gram stain.¿ (b)(6) 2020: (b)(6) hospital laboratories.(b)(6) md.Pathology report.A.¿infected mesh¿: gross diagnosis only.B.Fistula: ¿skin with granulation tissue-lined fistula tract, dermal fibrosis and reactive epidermal changes.¿ gross description: a.¿the specimen is received fresh labeled ¿infected mesh and consists of a single fragment of white-tan material consistent with mesh measuring 10.5 x 8.5 x 0.2 cm.The specimen is submitted for gross diagnosis only.¿ b: ¿the specimen is received in formalin labeled ¿fistula¿ and consists of a single pink-tan unoriented skin with underlying subcutaneous tissue measuring 2.7 x 1.0 and excised to a depth of 2.0 cm.The resection margin is inked black.Additionally seen on the skin surface is a cavitated defect measuring 1.7 x 0.3 cm which is abutting the margin.The specimen is longitudinally sectioned with a full-thickness section submitted in cassette b1.¿ (b)(6) 2020: (b)(6) health care.(b)(6) md; (b)(6) md.Discharge summary.Admitting diagnosis: infected hernioplasty mesh.Discharge diagnosis: infected hernioplasty mesh.55-year-old gentleman with hx opioid abuse disorder and recurrent ventral incisional hernia with infected mesh, presenting for scheduled hernia repair.(b)(6) 2020, scheduled surgery.Postoperative course complicated by aki, resolved with iv fluids and discontinuation of nephrotoxic drugs.Wound vac change 11/11, removed 11/13, abdominal wound closed at bedside without difficulty.On discharge, afebrile, ambulating, tolerating po pain medicine, voiding, tolerating regular diet.Discharged with one jp drain.Follow up with dr.(b)(6), (b)(6) 2020.Abdominal binder in place.Appropriately tender around incisions.No lifting more than 10 [lbs] for 60 days.Wear abdominal binder at all times.No heavy lifting or strenuous activity for 8 weeks.Follow up in (b)(6) clinic with dr.(b)(6).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-tex® suture 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-tex® suture 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.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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H6: health effect impact code: f1903: device explant.H6: medical device component: g0405215 suture thread.The investigation has been completed.Based upon the totality of the information received over the course of the investigation and reported by gore in the previously submitted medical record narratives the following conclusions have been reached.As previously reported, all pertinent medical records requested may not have been received.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.It should be noted that the gore-tex® suture instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions associated with the use of any suture include, but are not limited to, tissue dehiscence, infection, localized inflammatory reaction, and transitory local irritation.Broken needles or damaged thread may result in extended or additional surgery or retained foreign bodies.¿ the instructions for use further warn: ¿tissue invasion of the gore-tex® suture can result in attachment of the suture to the tissue it penetrates.Such attachment may make removal of the gore-tex® suture difficult.¿ procedure and specific patient factors may contribute to or cause infection, leading to contamination, exposure, lack of incorporation and/or seeding of device.Procedure related factors may include adherence to clinical guidelines on infection risk management, contamination of device prior to or during implant, and post-operative persistent/symptomatic seroma and wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.There is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code ¿d15: cause not established¿ is being used.Insufficient information may include limited or missing relevant medical records, involvement of multiple implanted devices (including non-gore devices) in the field of treatment, patient non-compliance, and/or a general lack of available detail or specificity related to an adverse event and/or device.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.After multiple requests, specific lot number information was not provided for this device, but product type has been confirmed.Review of the manufacturing and sterilization records could not be performed as a valid lot number was not provided.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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