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	01/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the delivery system was stuck on the wire.A 6x150x130 innova stent was selected to treat a previously placed 6x120 non-bsc stent in the left superficial femoral artery (sfa).Vascular access was gained through the left groin.A.035 260cm magic torque guidewire was advanced and the lesion was pre-dilated with a 6x200 mustang balloon catheter.The innova stent was then advanced and deployed successfully.Following deployment, the stent delivery system was not able to be removed over the wire.The delivery system was stuck on the wire.Everything but the sheath was removed together from the patient.A new wire was inserted, and the stent was post dilated with the 6x200 mustang balloon catheter.There were no patient complications and the procedure was completed.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a innova self-expanding stent system with a 0.035 guidewire stuck in the device.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the handle is opened.Microscopic examination revealed no additional damages.The stent was deployed and did not return with the device.There is blood present on the device.There are visible kinks to the guidewire at the distal end of the device near the clip.Attempts to remove the wire was unsuccessful so that device was soaked in a water bath.After a few days the wire was able to be removed and there were a lot of dried blood present on the wire.After the wire was removed from the device it was noticed that the wire had several kinks along it.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed that the wire froze on the device and was likely caused by the guidewire.
Event or Problem Description
It was reported that the delivery system was stuck on the wire.A 6x150x130 innova stent was selected to treat a previously placed 6x120 non-bsc stent in the left superficial femoral artery (sfa).Vascular access was gained through the left groin.A.035 260cm magic torque guidewire was advanced and the lesion was pre-dilated with a 6x200 mustang balloon catheter.The innova stent was then advanced and deployed successfully.Following deployment, the stent delivery system was not able to be removed over the wire.The delivery system was stuck on the wire.Everything but the sheath was removed together from the patient.A new wire was inserted, and the stent was post dilated with the 6x200 mustang balloon catheter.There were no patient complications and the procedure was completed.

• 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: 8293616
• Report Number: 2134265-2019-00572
• Device Sequence Number: 1588081
• 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): 02/13/2019

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: 07/31/2019
• Device Model Number: 26926
• Device Catalogue Number: 26926
• Device Lot Number: 0019454522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Initial Date Received by Manufacturer: 01/15/2019
• Supplement Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 01/31/2019
• Supplement Report FDA Received Date: 02/13/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: .035 260CM MAGIC TORQUE GUIDEWIRE; .035 260CM MAGIC TORQUE GUIDEWIRE; .035 260CM MAGIC TORQUE GUIDEWIRE
• Patient Age: 64 YR