MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION VASCU-GUARD; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Catalog Number	VG0106N
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	06/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent a left popliteal arterial surgery in which vascu-guard patches were used.This was further specified as ¿a longitudinal incision was made, and the patch was inserted¿ and ¿there was no reinforcement¿.Approximately five years and three months later, an aneurysm was diagnosed and subsequently resected.It was reported the aneurysm originated from the center of the device.Additional treatment or medical interventions were not reported.At the time of this report, the patient outcome was not reported.No additional information is available.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
B5: upon follow up it was reported "the vascu-guard was used to patch the vessel, no infection situation".The device and two (2) photographs of the sample were provided for evaluation.The pictures showed the resected aneurysm.It is not clear from the pictures whether any of the tissue shown is the vascu-guard patch.Neither the involvement of the patch or the alleged origin of the aneurysm in the center of the patch cannot be determined.The actual sample was received almost two months after it was excised from the patient and had been placed in a fixative.Evaluation determined that the provided pictures showed a more accurate depicted state of the sample immediately after it was removed.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: VASCU-GUARD
• Common Device Name: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave w; saint paul MN 55114
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 17342274
• Report Number: 1416980-2023-03620
• Device Sequence Number: 6543651
• Product Code: DXZ
• UDI-Device Identifier: 00085412530871
• UDI-Public: (01)00085412530871
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K983602
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2023

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: 09/06/2021
• Device Catalogue Number: VG0106N
• Device Lot Number: SP17B24-1215474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2023
• Supplement Date Received by Manufacturer: 08/04/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 08/15/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BOVINE PERICARDIAL PATCH (SYNOVIS); XARELTO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male