MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. FLAIR ENDOVASCULAR STENT GRAFT

Catalog Number UNKNOWN FLAIR

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Injury (2348)

Event Date 04/17/2020

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation, however, and image was provided for review.The investigation of the reported event is currently underway.

Event Description

It was reported that approximately two years post stent graft placement in the left axillary vein, the stent graft allegedly migrated to the heart/lung area.The patient is reportedly stable.

Manufacturer Narrative

H10: manufacturing review: the lot number was not provided; therefore, a device history record review was not performed.Investigation summary: the sample was not returned for evaluation.Two x-ray images were provided that were uninterpretable.Thus, the investigation is inconclusive for the reported migration of the stent graft.The definitive root cause for the migration of the implant could not be determined upon the available information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.

Event Description

It was reported that approximately two years post stent graft placement in the left axillary vein, the stent graft allegedly migrated to the heart/lung area.The patient is reportedly stable.

• Brand Name: FLAIR ENDOVASCULAR STENT GRAFT
• Type of Device: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10092097
• MDR Text Key: 192181218
• Report Number: 2020394-2020-03506
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN FLAIR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 55 YR