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

Catalog Number UNKNOWN GRAFT

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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.Journal article review: a 70-year-old diabetic man was seen for non-healing toe amputation sites on the right foot.He had undergone two previous revascularizations in each lower extremity and had no veins remaining for use as a bypass.The patient underwent a right femoral-perineal bypass with a 6 mm thin-walled ringed impra eptfe graft.During the preparation of the eptfe graft the external beading was gradually removed parallel to the axis of the graft.Approximately 20% of the beading was removed when it sheared through the graft.The remaining length of the eptfe was enough for the femoral-perineal bypass and was completed without incident.The remainder of the procedure was uneventful and the patient did well postoperatively.Patient was discharged five days post-operative procedure.Friedman, s.(2002).Fracture of an impra eptfe graft caused by removal of the beading.Ejves extra, 3(1), 6-7.Doi:10.1053/ejvx.2002.0112.

Event Description

It was reported in an article in elsevier science titled ¿fracture of an impra eptfe graft caused by removal of the beading¿, prior to patient contact approximately 20% of the eptfe graft tore during removal of the external beading; the same graft was used to perform a femoral-perineal bypass without incident.The patient was stable in good condition post-surgical procedure.

• 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: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 8203501
• MDR Text Key: 131710719
• Report Number: 2020394-2018-02256
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K004011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN GRAFT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/28/2018
• 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
• Patient Age: 70 YR