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

Model Number 26921

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2020

Event Type  malfunction  

Event Description

It was reported that the stent partially deployed.A 7mm x 150mm x 130cm innova was selected for a procedure in the bilateral iliac artery.During the procedure, the stent could not deploy past 120mm.Rotation of the thumbwheel had no response and the pull grip was unable to be pulled.The stent was deployed by manual pulling and the procedure was completed.There were no patient complications reported and the patient was stable post procedure.

Manufacturer Narrative

Device evaluation by manufacturer: returned product consisted of an innova self-expanding stent system.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 inner liner is kinked 15cm from the tip.Microscopic examination revealed no additional damages.The stent is deployed and did not return for analysis.Inspection of the remainder of the device, revealed no other damage or irregularities.

Event Description

It was reported that the stent partially deployed.A 7mm x 150mm x 130cm innova was selected for a procedure in the bilateral iliac artery.During the procedure, the stent could not deploy past 120mm.Rotation of the thumbwheel had no response and the pull grip was unable to be pulled.The stent was deployed by manual pulling and the procedure was completed.There were no patient complications reported and 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: 10935782
• MDR Text Key: 219351381
• Report Number: 2134265-2020-16799
• 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: 01/20/2021

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 Expiration Date: 08/16/2021
• Device Model Number: 26921
• Device Catalogue Number: 26921
• Device Lot Number: 0022527803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Initial Date Manufacturer Received: 11/23/2020
• Initial Date FDA Received: 12/02/2020
• Supplement Dates Manufacturer Received: 01/14/2021
• Supplement Dates FDA Received: 01/21/2021
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 60