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

Model Number	26926
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device became stuck on the guidewire.An innova 6x150x130 self expanding stent was selected to be implanted in the superficial femoral artery (sfa).After the stent was successfully deployed, the catheter became stuck on the wire upon retrieval.The deployment system and wire were successfully removed from the patient.There were no patient complications and the patient is fine.
Additional Manufacturer Narrative
Device analysis by mfr: the returned product consisted of an innova self-expanding stent system with an unknown 0.035" guidewire inside the device.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the pull rack is bent.There is a kink to the outer sheath at the nosecone.Microscopic examination revealed no additional damages.The wire was unable to be removed initially so it was x-rayed to see if there were any damages in the handle.No additional damages were seen so the device was placed in a water bath.After soaking, the wire was able to be removed.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the device became stuck on the guidewire.An innova 6x150x130 self expanding stent was selected to be implanted in the superficial femoral artery (sfa).After the stent was successfully deployed, the catheter became stuck on the wire upon retrieval.The deployment system and wire were successfully removed from the patient.There were no patient complications and the patient is fine.

• Brand Name: INNOVA VASCULAR
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8846235
• Report Number: 2134265-2019-08973
• Device Sequence Number: 2361522
• Product Code: NIP
• UDI-Device Identifier: 08714729874041
• UDI-Public: 08714729874041
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/10/2022
• Device Model Number: 26926
• Device Catalogue Number: 26926
• Device Lot Number: 0023930913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1