MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INNOVA; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number 26921

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2021

Event Type  malfunction  

Event Description

It was reported that stent foreshortening occurred.The 90% stenosed target lesion was located in the moderately calcified and on tortuous right common iliac to the external iliac artery.An innova self-expanding stent was implanted without issue.The physician observed the vessels and feels there was stent shortening after implant.There were no patient complications and no additional intervention is planned.

Manufacturer Narrative

H3 - device evaluated by manufacturer: the device remains implanted, therefore, device analysis could not be completed.Procedural imaging was provided to assist in the investigation and was reviewed by a boston scientific quality engineer.Foreshortening of the placed stent was confirmed by media review.

Event Description

It was reported that stent foreshortening occurred.The 90% stenosed target lesion was located in the moderately calcified and on tortuous right common iliac to the external iliac artery.An innova self-expanding stent was implanted without issue.The physician observed the vessels and feels there was stent shortening after implant.There were no patient complications and no additional intervention is planned.

• Brand Name: INNOVA
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12465600
• MDR Text Key: 271258708
• Report Number: 2134265-2021-11483
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2023
• Device Model Number: 26921
• Device Catalogue Number: 26921
• Device Lot Number: 0025895358
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2021
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 82