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

Model Number 26921

Device Problem Defective Device (2588)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2021

Event Type  Injury  

Event Description

It was reported the stent was shortened.A 5mm x 150mm x 130cm innova was selected for a procedure in the occluded superficial femoral artery.Pre-dilation was performed with a 4mm x 150mm balloon.When the stent was implanted, it was found to be shorter than the lesion length.A 5mm x 40mm innova was additionally implanted.There were no patient complications reported the patient was stable post procedure.

Manufacturer Narrative

Device eval by manufacturer: returned product consisted of an innova self-expanding stent system.The stent did not return for analysis as it was implanted.The outer sheath, tip, inner sheath, and the remainder of the device were checked for damage.Visual examination revealed a kink to the outer sheath at the nosecone.The distal section of the pull rack was separated inside the handle.The proximal section of the separated pull rack was missing.Microscopic examination revealed no additional damages.Inspection of the remainder of the device revealed no other damage or irregularities.

Event Description

It was reported the stent was shortened.A 5mm x 150mm x 130cm innova was selected for a procedure in the occluded superficial femoral artery.Pre-dilation was performed with a 4mmx150mm balloon.When the stent was implanted, it was found to be shorter than the lesion length.A 5mm x 40mm innova was additionally implanted.There were no patient complications reported the patient was stable post procedure.

• 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: 11230842
• MDR Text Key: 228696804
• Report Number: 2134265-2021-00795
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 02/17/2021

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 Expiration Date: 07/10/2023
• Device Model Number: 26921
• Device Catalogue Number: 26921
• Device Lot Number: 0025690539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Initial Date Manufacturer Received: 01/15/2021
• Initial Date FDA Received: 01/26/2021
• Supplement Dates Manufacturer Received: 02/03/2021
• Supplement Dates FDA Received: 02/17/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 75