MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRIO ST; SURGICAL MESH

Catalog Number	5950080
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Bowel Perforation (2668)
Date of Event	09/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, the degree to which the mesh implant may have caused or contributed to the reported bowel perforation cannot be determined.The explanted sample was discarded by the user facility and therefore, unavailable for review.No conclusions can be made.A lot number was not provided; without a lot number a review of the manufacturing records is not possible.Should additional information be provided, a supplemental emdr will be submitted.Discarded.
Event or Problem Description
It was reported that on (b)(6) 2019 the patient underwent the repair of a ventral incisional hernia and was implanted with a bard ventrio st mesh.On (b)(6) 2019, the patient presented with abdominal pain.Contrast ct revealed that there was perforation of the small bowel.On (b)(6) 2019, the patient underwent surgery for the repair of the perforated bowel and mesh removal.The perforation was closed by suturing.During the surgery, the doctor did not find that the mesh was adhered to the small bowel.No other patient injury was reported.
Additional Manufacturer Narrative
Based on the information provided, the degree to which the mesh implant may have caused or contributed to the reported bowel perforation cannot be determined.The explanted sample was discarded by the user facility and therefore, unavailable for review.No conclusions can be made.A lot number was not provided; without a lot number a review of the manufacturing records is not possible.Should additional information be provided, a supplemental emdr will be submitted.This is an addendum to the initial emdr to document product information was provided.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date this is the only reported complaint for the manufacturing lot of (b)(4) units released for distribution in february, 2019 discarded.
Event or Problem Description
It was reported that on (b)(6) 2019 the patient underwent the repair of a ventral incisional hernia and was implanted with a bard ventrio st mesh.On (b)(6) 2019, the patient presented with abdominal pain.Contrast ct revealed that there was perforation of the small bowel.On (b)(6) 2019, the patient underwent surgery for the repair of the perforated bowel and mesh removal.The perforation was closed by suturing.During the surgery, the doctor did not find that the mesh was adhered to the small bowel.No other patient injury was reported.

• Brand Name: VENTRIO ST
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 9125360
• Report Number: 1213643-2019-09343
• Device Sequence Number: 19538019
• Product Code: FTL
• UDI-Device Identifier: 00801741031571
• UDI-Public: (01)00801741031571
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2021
• Device Catalogue Number: 5950080
• Device Lot Number: HUCY1793
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/06/2019
• Supplement Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Weight: 75