MAUDE Adverse Event Report: ETHICON INC. PROCEED VENTRAL PATCH; MESH, SURGICAL, POLYMERIC

Catalog Number PVPM1

Device Problems Break (1069); Peeled/Delaminated (1454); Tear, Rip or Hole in Device Packaging (2385); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The review of the batch manufacturing records was conducted, and the batch met all finished goods release criteria.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.It was reported that the device "broke" while being implanted.Please indicate what portion of the mesh "broke" for example was it the mesh tabs, nonabsorbable pds sutures attached to the mesh tabs or did the mesh tear during insertion?.

Event Description

It was reported that the patient underwent a ventral hernia repair on 10/11/2018 and the mesh was implanted.When inserting into patient, the mesh broke.There were no patient consequences reported.Another like device was used to complete the procedure.Additional information has been requested.

Manufacturer Narrative

Date sent to the fda: 11/28/2018.Additional information was requested, and the following was obtained: it was reported that the device "broke" while being implanted.Please indicate what portion of the mesh "broke" for example was it the mesh tabs, nonabsorbable pds sutures attached to the mesh tabs or did the mesh tear during insertion? the doctor explains that the mesh broke as she was placing the mesh into the open defect with some sponge graspers.By this she means that the tissue separating component of the mesh broke away from the prolene part of the mesh - the mesh separated into 2 pieces.Therefore, a doctor was not able to use the mesh.

Manufacturer Narrative

Date sent to the fda: 01/06/2019.Additional summary: an empty opened foil, opened folder and a proceed ventral patch were returned for analysis.During visual inspection of the sample, body fluids on the mesh was noted; also, the two wings were partially broken, due to the ventral patch has begun with degradation process.In the visual inspection of opened foil, showed excessive manipulation and multiples holes on the wrinkles consistent with excessive manipulation.The seal area was examined visually, and it was noted to be complete and no damaged or wrinkles were present.Per the foil condition the assignable cause of the performance - loss of integrity - intra op was a result of pin holes in the foil consistent with excessive manipulation resulting in a degradation of the mesh ventral patch.

• Brand Name: PROCEED VENTRAL PATCH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8044660
• MDR Text Key: 126510045
• Report Number: 2210968-2018-76996
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K061533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: PVPM1
• Device Lot Number: MA8BSRB0
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/11/2018
• Patient Sequence Number: 1