MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE BIO-A TISSUE REINFORCEMENT; MESH, SURGICAL, POLYMERIC

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Dysphagia/ Odynophagia (1815); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

Several attempts were made to obtain information regarding this event, including device identification (lot/serial, catalog numbers), device availability and detailed information about the event.Product identification records for an alleged gore device were not provided.Therefore, review of manufacturing records and direct product analysis could not be performed.Per the instructions for use, ¿the implanted gore® bio-a® tissue reinforcement is a porous fibrous structure composed solely of synthetic bioabsorbable poly (glycolide: trimethylene carbonate) copolymer.Degraded via a combination of hydrolytic and enzymatic pathways, the copolymer has been found to be both biocompatible and nonantigenic.In vivo studies with this copolymer indicate the bioabsorption process should be complete by six to seven months.¿ based on the reported event, it could not be confirmed that the device was gore® bio-a® tissue reinforcement.

Event Description

It was reported that a gore bio-a tissue reinforcement was found "encapsulated" one year after implant.Per the physician, the patient presented with dysphagia 1 year after nissen/hiatal hernia repair and buttress with a gore bio-a tissue reinforcement.At reoperation it was noticed that the gore bio-a tissue reinforcement had not been changed after over one year in the body.It appeared as though it was straight out of the box.The physician thinks this is an idiosyncratic reaction that patients can have to biologic or other absorbable meshes; in this case walling it off and somehow preventing it from the hydration/absorption process usually seen.

Manufacturer Narrative

In a podium presentation at the (b)(6) surgical meeting in (b)(6) on (b)(6) 2016 the following information was presented: title- #27 video-laparoscopic revision of fundoplication and hiatal hernia repair with explant of biologic synthetic mesh causing hiatal stenosis.(b)(6): "implementation of mesh prostheses for crural reinforcement in hiatal hernia repair remains a debated topic.Synthetic meshes are known to be associated with risk of erosion or stenosis resulting in dysphagia.Biologic meshes are hypothesized to diminish these risks due to their absorbability.In this video we show a revisional operation for a patient who had previously undergone fundoplication and hiatal hernia repair with use of biosynthetic mesh for reinforcement of the crura.He developed progressive dysphagia refractory to endoscopic balloon dilation, and preoperative study showed hiatal stenosis.At the time of surgery, exposure of the hiatus showed that the mesh had undergone minimal resorption and had persisted as an inflammatory foreign body.The patient underwent resection, and re-do fundoplication and hiatal hernia repair without prosthetic reinforcement.Post-operative swallow study showed ready passage of contrast beyond the gastroesophageal junction.In conclusion, biosynthetic meshes may exhibit permanence more akin to synthetic materials, and their use in hiatal hernia repair should be re-considered".The abstract from the podium presentation has not be published, therefore cannot be attached to the report.

• Brand Name: GORE BIO-A TISSUE REINFORCEMENT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MPD APC B/P; p.o. box 1408; elkton MD 21922 1408
• Manufacturer Contact: cheryl hawke ; 301 airport rd.; elkton, MD ; 9285263030
• MDR Report Key: 5163273
• MDR Text Key: 28826776
• Report Number: 3003910212-2015-00049
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033671
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 68 YR