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

Model Number 40S06

Device Problem Obstruction of Flow (2423)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 08/06/2020

Event Type  Injury  

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 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
• Type of Device: EPTFE VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 11018518
• MDR Text Key: 221744143
• Report Number: 2020394-2020-20845
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00801741021831
• UDI-Public: (01)00801741021831
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K004011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 40S06
• Device Catalogue Number: 40S06
• Device Lot Number: VTAP0037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 12/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: ALLOPURINOL, BISOPROLOL FUMARATE; FUROSEMIDE, CALCIUM CARBONATE; INSULIN HUMAN, AND ACETYLSALICYLIC ACID; PANTOPRAZOLE, PERINDOPRIL ARGININE, ALFACALCIDOL
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 120