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

Model Number	40S06
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Stenosis (2263); Thrombosis/Thrombus (4440)
Date of Event	09/19/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through the results of a clinical trial that post conduit implant inserted surgically, the patient experienced the events of hematoma outside the arteriovenous graft (avg), thrombosis of vascular access with moderate intensity and stenosis of vascular access with moderate intensity, which resulted in hospitalization.The subject underwent thrombectomy and angioplasty and the event of thrombosis of vascular access was considered resolved and the event of stenosis remained unresolved.The events were definitely related to the study conduit and not related to the study procedure.The current status of the patient is unknown.
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause could not be determined based upon the available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.

• Brand Name: IMPRA VASCULAR GRAFT
• Common Device Name: 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: 12958340
• Report Number: 2020394-2021-02044
• Device Sequence Number: 20196173
• Product Code: DSY
• UDI-Device Identifier: 00801741021831
• UDI-Public: (01)00801741021831
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K004011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/17/2021

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2021
• Initial Report FDA Received Date: 12/08/2021
• 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: ALFACALCIDOL, RANITIDINE, CLOPIDOGREL; AMLODIPINE, BUPRENORPHINE, CALCIUM ACETATE; CODEINE PHOSPHATE/PARACETAMOL; DARBEPOETIN ALFA, FUROSEMIDE AND INSULIN LISPRO
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Race: Black Or African American