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

Catalog Number	5950090
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Purulent Discharge (1812); Erythema (1840); Fistula (1862)
Date of Event	03/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, post implant of ventrio st mesh the patient experienced adverse symptoms resulting in subsequent mesh removal.The information provided is limited and does not help to determine root cause for the patient¿s postoperative course, no conclusions can be made.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Adhesions and fistula formation are known inherent risks of surgery and are identified as possible complications in the adverse reactions section of the instructions-for-use, supplied with the device.Note, the documented date of event (01-mar-2024) is considered to be a best estimate.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.
Event or Problem Description
As reported the case was a woman in her 80s.Thirteen (13) years ago she underwent an open sigmoid colon resection for sigmoid colon cancer and five (5) years ago, presented with an abdominal wall scar hernia.Open abdominal wall scar hernia repair was performed, and the patient was implanted with a ventrio st mesh.Four (4) months later redness, pain, and leakage of intestinal fluid from the wound were observed.Conservative treatment, including antimicrobials, failed to improve the situation.Abdominal wall resection including mesh was performed.Reportedly the mesh was adherent to the small intestine and formed a fistula.
Additional Manufacturer Narrative
As reported, post implant of ventrio st mesh the patient experienced adverse symptoms resulting in subsequent mesh removal.The information provided is limited and does not help to determine root cause for the patient¿s postoperative course, no conclusions can be made.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Adhesions and fistula formation are known inherent risks of surgery and are identified as possible complications in the adverse reactions section of the instructions-for-use, supplied with the device.Note, the documented date of event (01-mar-2024) is considered to be a best estimate.Addendum: h11: this supplemental mdr is submitted to correct the imdrf annex b code.Updated fields: b4, g3, g6, h2, h10, h11 corrected field: h6 (imdrf annex b grid) 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.
Event or Problem Description
As reported the case was a woman in her 80s.Thirteen (13) years ago she underwent an open sigmoid colon resection for sigmoid colon cancer and five (5) years ago, presented with an abdominal wall scar hernia.Open abdominal wall scar hernia repair was performed, and the patient was implanted with a ventrio st mesh.Four (4) months later redness, pain, and leakage of intestinal fluid from the wound were observed.Conservative treatment, including antimicrobials, failed to improve the situation.Abdominal wall resection including mesh was performed.Reportedly the mesh was adherent to the small intestine and formed a fistula.

• Brand Name: VENTRIO ST
• 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: 18958631
• Report Number: 1213643-2024-00099
• Device Sequence Number: 14587876
• Product Code: FTL
• UDI-Device Identifier: 00801741031588
• UDI-Public: (01)00801741031588
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2024

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 Catalogue Number: 5950090
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2024
• Supplement Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Female