MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. IMPRA EPTFE VASCULAR GRAFT

Model Number	40S06
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	08/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 01/2021).
Event or Problem Description
It was reported through a clinical trial that approximately 1225 days post study conduit placement, there was thrombosis of vascular access.Approximately 1261 days post study conduit placement, the patient was hospitalized due to thrombosis of vascular access.Approximately 1262 days post study conduit placement, the subject underwent a thrombectomy and the event was considered resolved.The same day, the patient experienced a second thrombosis of vascular access which prolonged hospitalization.Approximately 1265 days post study conduit placement, the patient underwent a repeat thrombectomy with angioplasty.The thrombosis was resolved the same day and the patient was discharged the following day post uneventful dialysis.The current status of the patient was not provided.

• Brand Name: IMPRA EPTFE VASCULAR GRAFT
• Common Device Name: EPTFE VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11018518
• Report Number: 2020394-2020-20845
• Device Sequence Number: 3822818
• Product Code: DSY
• UDI-Device Identifier: 00801741021831
• UDI-Public: (01)00801741021831
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K004011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,other,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/20/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 40S06
• Device Catalogue Number: 40S06
• Device Lot Number: VTAP0037
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALLOPURINOL, BISOPROLOL FUMARATE; FUROSEMIDE, CALCIUM CARBONATE; INSULIN HUMAN, AND ACETYLSALICYLIC ACID; PANTOPRAZOLE, PERINDOPRIL ARGININE, ALFACALCIDOL
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Weight: 120