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

Catalog Number	5955610
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	09/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, about nine months post-implant of the bard/davol ventralight st mesh using echo ps, the patient was diagnosed with small bowel obstruction and hospitalized.As reported, the ae is resolved.The clinician has assessed the patient¿s postoperative course as being possibly related to the study device and to the procedure, however, based on the information provided, no conclusion can be made.Review of manufacturing records confirms product was manufactured to specification.Not returned - remains implanted.
Event or Problem Description
Reported per clinical trial (b)(4): (b)(6) 2018 - subject patient underwent a robotic assisted midline subxyphoid, epigastric, and umbilical first-time recurrent hernia (15x7 cm) repair procedure.A ventralight st mesh was placed using w/echo ps and fixated using a bard/davol optifix fixation device along with non-bard/davol prolene and v-loc sutures.The patient was discharged to home on (b)(6) 2018.(b)(6) 2018 - subject patient was diagnosed with small bowel obstruction and was hospitalized.(b)(6) 2018 - the ae resolved, the patient was discharged.Per the study clinician, the reported adverse event has been assessed as mild in severity, possibly related to the study device and possibly related to the index procedure.The outcome for this ae is reported as recovered/resolved.

• Brand Name: VENTRALIGHT ST W/ ECHO
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 14461911
• Report Number: 1213643-2022-00263
• Device Sequence Number: 14578913
• Product Code: FTL
• UDI-Device Identifier: 00801741031748
• UDI-Public: (01)00801741031748
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K122436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Study,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/10/2022

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: 10/28/2018
• Device Catalogue Number: 5955610
• Device Lot Number: HUAX1302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 71 KG