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

Model Number 40S06

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Stenosis (2263); Thrombosis/Thrombus (4440)

Event Date 09/19/2017

Event Type  Injury  

Event 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.

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
• 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: 12958340
• MDR Text Key: 281908509
• Report Number: 2020394-2021-02044
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00801741021831
• UDI-Public: (01)00801741021831
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K004011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 11/12/2021
• Initial Date FDA Received: 12/08/2021
• 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: ALFACALCIDOL, RANITIDINE, CLOPIDOGREL; AMLODIPINE, BUPRENORPHINE, CALCIUM ACETATE; CODEINE PHOSPHATE/PARACETAMOL; DARBEPOETIN ALFA, FUROSEMIDE AND INSULIN LISPRO
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Race: Black Or African American