MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST MESH; SURGICAL MESH

Catalog Number	5954600
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Obstruction/Occlusion (2422)
Date of Event	08/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, post implant of the bard/davol ventralight st mesh fixated using bard/davol capsure fasteners, the patient experienced bowel obstruction, adhesions and underwent surgical intervention for mesh explant.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in april 2021.A photo of the explanted mesh and capsure fasteners was provided.Evaluation of the images do not allow for any conclusions to be made.Per instructions-for-use, supplied with the device, adhesion is identified as a possible post-surgical complication.Ifu notes to, ¿ensure proper orientation; the coated side of the prosthesis should be oriented against the bowel or sensitive organs.Do not place the polypropylene side against the bowel.There may be a possibility for adhesion formation when the polypropylene side is placed in direct contact with the bowel or viscera¿.This mdr represents the bard/davol ventralight st mesh and an additional mdr will be submitted to represent the bard/davol capsure straight.Mesh explanted.
Event or Problem Description
As reported, a patient underwent implant of a bard/davol ventralight st mesh (device #1) on (b)(6) 2021, which was fixated using a bard/davol capsure fixation device (device #2).As reported, the patient developed bowel obstruction a week later which was managed by conservative methods (nil oral).About 3-4 days later, the patient developed bowel obstruction again; a ct-scan showed bowel adhesion at the umbilical region.The patient underwent an exploratory laparoscopy on (b)(6) 2021, during which the bowel was noted to be densely adhered to the mesh.Both the mesh and the capsure fasteners were removed.

• Brand Name: VENTRALIGHT ST MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 12519276
• Report Number: 1213643-2021-20336
• Device Sequence Number: 17141345
• Product Code: FTL
• UDI-Device Identifier: 00801741031632
• UDI-Public: (01)00801741031632
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/08/2021

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: 12/28/2022
• Device Catalogue Number: 5954600
• Device Lot Number: HUFN1896
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 09/23/2021
• 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: 60 YR