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

Catalog Number 5950008G

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Purulent Discharge (1812); Seroma (2069); Obstruction/Occlusion (2422)

Event Date 09/28/2022

Event Type  Injury  

Event Description

As reported, the patient underwent ventral repair for cure of supra-umbilical eventration with the implant of bard/davol ventralex st on (b)(6) 2022.It was reported that after 8 days of cure, the patient presented to the emergency room with abdominal pain, vomiting, diarrhea and hyperthermia for 2 days and hospitalized on (b)(6) 2022.It was reported that the patient was discharged home with an encapsulated fluid collection of 42 x 22 x 27 mm in front of the surgical approach and re-consulted on day 10 for a recurrence of fever and vomiting.It was reported that release of the digestive tracts which had stuck to the plate.It was also reported that the patient underwent laparoscopy with conversion to laparotomy for an occlusive syndrome on (b)(6) 2022.As reported, intraoperative findings revealed very tight and unusual adhesions of the small intestine.It was reported that the resection of 40 cm small bowel was required, and the plaque was removed.It was reported that after 25 days ((b)(6) 2022) need to reopen the wound for about 5 mm in length, allowing serosanguineous fluid to flow in favor of a non-superinfected seroma and 6 days after ((b)(6) 2022) patient is in the process of healing.

Manufacturer Narrative

Based on the information provided, no conclusions can be made.As reported post implant of the ventralex st mesh the patient experienced adverse events including adhesions and seroma.Adhesions and seroma formation are known inherent risks of surgery/use of the device.The adverse reaction section of the instructions-for-use, supplied with the device identifies adhesion and seroma as possible complications.The warning section of the ifu states, ¿ensure proper orientation; the bioresorbable 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 mesh (including strap) is placed in direct contact with the bowel or viscera.¿ review of manufacturing records confirms the product was manufactured to specification.To date, this is the only reported complaint from this manufacturing lot of (b)(4) units released for distribution in may, 2022.

Event Description

As reported, the patient underwent ventral repair for cure of supra-umbilical eventration with the implant of bard/davol ventralex st on (b)(6) 2022.It was reported that after 8 days of cure, the patient presented to the emergency room with abdominal pain, vomiting, diarrhea and hyperthermia for 2 days and hospitalized on (b)(6) 2022.It was reported that the patient was discharged home with an encapsulated fluid collection of 42 x 22 x 27mm in front of the surgical approach and re-consulted on day 10 for a recurrence of fever and vomiting.It was reported that release of the digestive tracts which had stuck to the plate.It was also reported that the patient underwent laparoscopy with conversion to laparotomy for an occlusive syndrome on (b)(6) 2022.As reported, intraoperative findings revealed very tight and unusual adhesions of the small intestine.It was reported that the resection of 40cm small bowel was required, and the plaque was removed.It was reported that after 25 days ((b)(6) 2022) need to reopen the wound for about 5 mm in length, allowing serosanguineous fluid to flow in favor of a non-superinfected seroma and 6 days after ((b)(6) 2022) patient is in the process of healing.

Manufacturer Narrative

Based on the information provided, no conclusions can be made.As reported post implant of the ventralex st mesh the patient experienced adverse events including adhesions and seroma.Adhesions and seroma formation are known inherent risks of surgery/use of the device.The adverse reaction section of the instructions-for-use, supplied with the device identifies adhesion and seroma as possible complications.The warning section of the ifu states, ¿ensure proper orientation; the bioresorbable 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 mesh (including strap) is placed in direct contact with the bowel or viscera.¿ review of manufacturing records confirms the product was manufactured to specification.To date, this is the only reported complaint from this manufacturing lot of (b)(4) units released for distribution in may, 2022.Addendum: h11: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to correct the initial reporter details and annex d code.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 : not returned.

• Brand Name: VENTRALEX ST
• Type of Device: 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: 15729788
• MDR Text Key: 303035334
• Report Number: 1213643-2022-00709
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741183706
• UDI-Public: (01)00801741183706
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K101928
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2023
• Device Catalogue Number: 5950008G
• Device Lot Number: HUGN1799
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 74 KG