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	Stenosis (2263)
Date of Event	12/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review could not 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.
Event or Problem Description
It was reported through the results of a clinical trial that approximately 847 days post study conduit placement in the left forearm the patient experienced stenosis of vascular access and was hospitalized.Surgery to augment outflow was performed and the event was considered resolved the same day.The patient was discharged one day post admission.The current status of the patient is unknown.

• 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: 8272403
• Report Number: 2020394-2019-00021
• Device Sequence Number: 158762
• Product Code: DSY
• UDI-Device Identifier: 00801741021831
• UDI-Public: (01)00801741021831
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K004011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/23/2019

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2018
• Initial Report FDA Received Date: 01/23/2019
• 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: CALCITRIOL, SENNOSIDE, PARACETAMOL; CALCIUM ACETATE, CINACALCET HYDROCHLORIDE; CALCIUM CARBONATE, COLECALCIFEROL; EPOETIN ALFA, CLONIDINE, FUROSEMIDE; LOSARTAN, SIMVASTATIN, WARFARIN, DOCUSATE SODIUM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 43 YR
• Patient Weight: 65