FDA Adverse Event Injury Summary report: N

IMPRA EPTFE VASCULAR GRAFT

MDR report key: 25252085 · Received May 22, 2026

Report

Report Number: 2020394-2026-01306
Event Type: Injury
Date Received: May 22, 2026
Date of Event: April 29, 2026
Report Date: May 7, 2026
Manufacturer: BARD PERIPHERAL VASCULAR, INC.
Product Code: DSY
UDI-DI: 00801741021411
PMA / PMN Number: K004011
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MX
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

H11: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. PHOTOS WERE PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. D2B (DSY; DYF). SECTION A THROUGH F: THE INFORMATION PROVIDE BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem · 0

ON (B)(6) 2026, A PATIENT UNDERWENT A SURGICAL GRAFT PLACEMENT PROCEDURE USING THE CARBOFLO GRAFT. DURING THE PROCEDURE, AN IMPRA GRAFT IMPLANTED IN AN ARTERIOVENOUS FISTULA WAS OBSERVED TO LEAK FROM MULTIPLE POINTS ALONG THE BODY OF THE GRAFT. INITIAL ASSESSMENT SUSPECTED BLEEDING AT THE ANASTOMOSIS, HOWEVER, AFTER COMPRESSION MANEUVERS, THE PHYSICIAN DETERMINED THAT THE LEAKAGE ORIGINATED DIFFUSELY FROM THE GRAFT BODY RATHER THAN THE ANASTOMOTIC SITE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
364392	IMPRA EPTFE VASCULAR GRAFT	EPTFE VASCULAR GRAFT	DSY	BARD PERIPHERAL VASCULAR, INC.		VTKW0089	00801741021411

Patients

Seq	Age	Sex	Outcome	Treatment
1