MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO 2; SURGICAL MESH

Catalog Number	5990011
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during laparoscopic ventral hernia repair procedure, the ventralight st w/ echo 2 mesh was used.It was reported that the surgeon hydrated the mesh for 1-3 seconds and rolled with the ps on the outside of the mesh instead of keeping it on the inside.It was reported that the surgeon pushed the mesh through the trocar into the abdomen and found that the ps came off from the mesh.It was reported that all the ps and the mesh were removed from the patient's body.The procedure was completed with a new mesh.There was no reported patient injury.
Additional Manufacturer Narrative
As reported, while deploying the ventralight st w/ echo 2 down a 10mm trocar with the ps frame rolled towards the outside the ps frame detached.A visual examination of the sample was performed finding there is a significant tear in the middle potion of the mesh and the ps is no longer attached.The ps was not returned with the sample.Based on the sample condition and information provided the ps frame detaching when being deployed through the trocar is the result of forces applied while inserting the mesh with the ps frame rolled outward, not inward as prescribed in the ifu.The frame detaching in use with forces applied resulted in the mesh tearing.Per the ifu " start at the bottom and roll the device tightly with the polypropylene side on the outside and bioresorbable barrier and echo 2¿ positioning system frame on the inside.Follow the nitinol frame outward as the mesh is rolled.Take care not to let the hoisting suture become rolled up with the mesh." note: section a through f - the information provided by bd 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 bd.H3 other text : sample evaluated.

• Brand Name: VENTRALIGHT ST W/ ECHO 2
• 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: 17564812
• Report Number: 1213643-2023-00293
• Device Sequence Number: 20499567
• Product Code: FTL
• UDI-Device Identifier: 00801741130977
• UDI-Public: (01)00801741130977
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K170294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/28/2023
• Device Catalogue Number: 5990011
• Device Lot Number: HUHN0160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2023
• 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: Other
• Patient Sex: Unknown