MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRALISHT ST W/ ECHO 2; SURGICAL MESH

Catalog Number	5991520
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Obstruction/Occlusion (2422)
Date of Event	09/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusion can be made.It is unclear what may have caused the adhesions/obstruction to present.Specific information regarding the implant and revision procedure was not provided.To date this is the only reported complaint for this production lot of (b)(4) units released for distribution in january, 2018.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Adhesion formation is a known inherent risk of surgery and is listed in the instructions-for-use as a possible complication.Should additional information be provided, a supplemental emdr will be submitted.Note: the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.Remains implanted.
Event or Problem Description
As reported, on (b)(6) 2018 the patient underwent a robotically assisted ventral incisional hernia repair with implant of the ventralight st mesh with echo 2.0 ps.About 2 weeks later, on (b)(6) 2018 the patient returned to the hospital and was taken to surgery where the surgeon discovered the mesh was adhered to a portion of the bowel and this was causing an obstruction.Due to short amount of time the mesh had been in place, the surgeon was able to separate the mesh from the bowel and there was no residual bowel injury.The patient remained hospitalized for observation.

• Brand Name: VENTRALISHT ST W/ ECHO 2
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 7953680
• Report Number: 1213643-2018-03473
• Device Sequence Number: 18939614
• Product Code: FTL
• UDI-Device Identifier: 00801741131004
• UDI-Public: (01)00801741131004
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K170294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/10/2018

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: 12/28/2018
• Device Catalogue Number: 5991520
• Device Lot Number: HUBX0984
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 10/10/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 74 YR