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

Model Number 26920

Device Problem Entrapment of Device (1212)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/24/2020

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

It was reported that guidewire entrapment occurred.The target lesion was located in the distal superficial femoral artery (sfa)/proximal popliteal artery.A 5x150x130 innova self expanding stent was deployed with no issues.After stent deployment, the delivery catheter was unable to be removed from the patient over the guidewire.The delivery system started to come back; however stopped just proximal to where the stent was deployed.A buddy wire was placed to maintain access and the stent and guidewire were removed together.After removal, the stent was unable to be removed from the guidewire outside the patient.The procedure was completed with a different guidewire.An innova 5.0x150x130, innova 5.0x120x130 and an epic 7.0x40x75 were deployed without incident.There were no patient complications reported.

Manufacturer Narrative

A2: age at time of event: 18 years or older.Device evaluated by mfr: returned product consisted of an innova self-expanding stent system with a 0.035 inch guidewire stuck inside it.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed a kink to the nosecone.Microscopic examination revealed no additional damages.The handle was opened and no additional damages were found.Inspection of the remainder of the device, revealed no other damage or irregularities.

Event Description

It was reported that guidewire entrapment occurred.The target lesion was located in the distal superficial femoral artery (sfa)/proximal popliteal artery.A 5x150x130 innova self expanding stent was deployed with no issues.After stent deployment, the delivery catheter was unable to be removed from the patient over the guidewire.The delivery system started to come back; however stopped just proximal to where the stent was deployed.A buddy wire was placed to maintain access and the stent and guidewire were removed together.After removal, the stent was unable to be removed from the guidewire outside the patient.The procedure was completed with a different guidewire.An innova 5.0x150x130, innova 5.0x120x130 and an epic 7.0x40x75 were deployed without incident.There were no patient complications reported.

• 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: 9958669
• MDR Text Key: 187703739
• Report Number: 2134265-2020-04998
• 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: 05/19/2020

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: 07/07/2022
• Device Model Number: 26920
• Device Catalogue Number: 26920
• Device Lot Number: 0024066053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2020
• Initial Date Manufacturer Received: 03/24/2020
• Initial Date FDA Received: 04/14/2020
• Supplement Dates Manufacturer Received: 04/28/2020
• Supplement Dates FDA Received: 05/19/2020
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE: COOK AMPLATZ STIFF WIRE; GUIDEWIRE: COOK AMPLATZ STIFF WIRE