MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® BIOMATERIAL; MESH, SURGICAL, POLYMERIC

Model Number 1DLMC03

Device Problem Insufficient Information (3190)

Patient Problems Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/20/2018

Event Type  Injury  

Event Description

It was reported to gore that the patient underwent open incisional hernia repair on (b)(6) 2015 whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2018, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: abdominal pain, adhesions, hernia recurrence, and mesh explant.Additional event specific information was not provided.

Manufacturer Narrative

It should be noted that the gore® dualmesh® 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.".

Manufacturer Narrative

H6: updated investigation findings code.Conclusion code remains unchanged it should be noted that the gore® dualmesh® 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® 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.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.

Manufacturer Narrative

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) 2015: (b(6) md.Indications: ¿this is a 68 - year -old gentleman who has previously undergone a left paramedian incision for splenectomy secondary to trauma.The patient indicates that the surgery was in the remote past.The patient has a longstanding incisional hernia.The hernia is described as small and reducible, yet symptomatic.The patient never had any obstructive symptoms.The patient was evaluated by another doctor and referred for possible surgery.Considering that the patient's hernia is symptomatic, he has wished to proceed with surgical repair.The patient is also known to have diastasis of the rectus muscle.He is not seeking repair of this at this time.The patient was found to have a 3 cm high x 5 cm long hernia defect oriented in the transverse direction.A 10 x 15 cm gore-tex mesh was used to cover the defect.The risks, benefits, and alternatives were thoroughly explained and the patient agreed to proceed.¿ implant procedure: laparoscopic incisional hernia repair with implantation of mesh.[implant: gore® dualmesh® biomaterial, 1dlmc03/ 13305744, 10 cm x 15 cm x 1 mm thick, oval] implant date: (b)(6) 2015 [hospitalization dates unknown].(b)(6) 2015: dr.(b)(6).Pre-and postoperative diagnosis: incisional hernia.Anesthesia: general.Estimated blood loss: minimal.Complications: none.Wound classification: ¿1 clean wound¿ findings: ¿a 3x5 cm incisional hernia in the epigastrium.¿ procedure: ¿the patient was brought into the operating room.He was identified by name.He was then sedated and intubated.He was prepped and draped in the usual fashion.A 5-mm incision was performed in the right upper quadrant and an optical access trocar was used to gain entry into the abdomen under direct vision.The abdomen was insufflated to the level of 15 mmhg.Inspection of the abdomen revealed a few adhesions off the omentum and transverse colon to the anterior abdominal wall.We added an additional 5-mm trocar in the right lower quadrant and 12-mm trocar in the lower midline.We proceeded to perform lysis of adhesions by dissecting the omentum and the transverse colon from the anterior abdominal wall.We used mostly blunt dissection in 1 area where the omentum was clearly adhered.Sharp dissection with electrocautery was used for dissection.We proceeded to clear the entire anterior abdominal wall.In doing so, we now were able to visualize the defect.The defect was 5 cm in the transverse direction and 3 cm in the longitudinal direction.There were no incarcerated contents within the defect except for some intra-abdominal fat.The area around the defect was healthy fascia and there were no satellite lesions.Considering the size of the defect and in order to gain adequate overlap of normal fascia, we decided to place a 10 x 15 cm gore-tex mesh.This mesh would adequately cover the defect and at least 3 to 4 cm of normal fascia in all directions.The mesh was prepared on the outside by placing transfascial fixation sutures at the transverse end of the mesh.The mesh was then folded and placed into the abdominal cavity through the 12-mm trocar site.The mesh was then unrolled.Using a suture passer, these transfascial fixation sutures were grasped and allowed the mesh to be brought up to the abdominal wall.We now examine the mesh and positioned in the transverse direction and were content with the amount of transverse overlap.The transfascial fixation sutures were now tied down.The mesh was then completely unrolled and positioned over the defect.We confirmed that the defect was in the center of the mesh and that there was adequate overlap of the defect.We then proceeded to place a series of spiral tax around the periphery of the mesh.These were placed 1 to 2 cm apart in order to prevent any gaps that could lead to acute obstruction.With the mesh now taunt and positioned well over the defect, we proceeded to add 2 additional transfascial fixation sutures.These were placed with the gore cv-2 sutures, one was placed in the superior aspect of the mesh and 1 in the inferior aspect of the mesh giving a total 4-point fixation.The abdomen was then checked for hemostasis and found to be intact.The 12-mm trocar site was then closed with an (sic) 0 vicryl suture using a suture passer.The abdomen was desufflated and trocars were removed.Skin was closed with subcuticular stitches.The patient went to recovery room in good condition.¿ (b)(6) 2015: (b)(6) medical center.Implant record: ¿type: mesh.Mfg [manufacturer]: gore.Lot #: 13305744.Serial #: [not provided].Catalog #: 1dlmc03.Size: 10x15x1.Amount: (b)(4).Exp.Date: 201910.¿ explant preoperative complaints: (b)(6) 2018: (b)(6) md.¿preoperative diagnosis: small -bowel obstruction status post multiple previous abdominal surgeries including prostatectomy, splenectomy, multiple ventral hernia repairs.¿ explant procedure: laparoscopic lysis of adhesions with conversion to open with explantation of multiple meshes, extensive lysis of adhesions from small bowel to small bowel and small bowel to mesh, bilateral component separation, i.E., myocutaneous flaps with repair of a ventral hernia, drainage.Explant date: date: (b)(6) 2018 [hospitalization dates unknown] (b)(6) 2018: (b)(6) md.Operative note: first assistant: dr.(b)(6).Pre- and postoperative diagnoses: small -bowel obstruction status post multiple previous abdominal surgeries including prostatectomy, splenectomy, multiple ventral hernia repairs.Anesthesia: general.Wound classification: [not provided] procedure: ¿the patient was given a gram of invanz, taken to the operating room and cleaned, prepped, and draped in standard fashion.We started by putting a 5 mm optiview port into the right upper quadrant and i then noticed that there were multiple adhesions, particularly to the previously placed meshes as well as metal tacks that had been placed previously.We started to take this down, but it was markedly difficult trying to get adequate visualization and therefore, we elected to open since we knew we were going to have to remove the meshes anyway, so we then aborted and we did a long midline incision and we explanted 3 different meshes (sic) sacs and took down multiple adhesions stuck to the undersurface of the mesh and stuck to the multiple previously placed metal screws.In one area, the bowel was attached to a screw and on taking it down, we noticed that the bowel was attached at the antimesenteric border to it, so we took that down and then repaired it with 3-8 vicryl and 3-0 silk.We then copiously irrigated after extensive lysis of adhesions and we did bilateral component separation with myocutaneous flap so that we could close without placing the mesh.We then closed the midline with #1 looped pds and then we placed two 19 -french drains on each side, washed out once more, and then closed the skin with skin staples.The patient was dressed with a binder and then returned to the recovery room in satisfactory condition.Needle and sponge count was correct.¿ pathology for specimens removed during the (b)(6) 2018 procedure was not provided.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® 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® 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.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.

• Brand Name: GORE® DUALMESH® BIOMATERIAL
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MPD APC B/P; p.o. box 1408; elkton MD 21922 1408
• Manufacturer Contact: vanessa rodriguez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14524033
• MDR Text Key: 292827243
• Report Number: 3003910212-2022-01368
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00733132600960
• UDI-Public: 00733132600960
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992189
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: 1DLMC03
• Device Catalogue Number: 1DLMC03
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 82 KG