MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE INNOVA¿; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	H74939293061530
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at the time of event: 18 years or older.(b)(4).
Event or Problem Description
It was reported that the delivery system was stuck on the wire.A 6 x 150 x 130 innova¿ stent was selected for an endovascular treatment (evt) procedure.The 99% stenosed, focal target lesion was located in the moderately tortuous left superficial femoral artery (sfa).The innova stent was advanced ipsilateral over a.035 non-bsc wire.Dilatation was performed using a coyote balloon and sfa stenting was performed.After deploying the stent, the physician attempted to remove the innova delivery system but the system became stuck on the wire.The delivery system was removed together with the wire and the procedure was completed.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an innova self-expanding stent delivery system (sds) with a.035 guidewire returned stuck in the device.The outer shaft, middle shaft and the remainder of the device were checked for damage.There was a slight kink at the nosecone.The stent was not returned.The guidewire that was returned with the device is coated with a hydrophilic coating.This coating must stay hydrated to stay lubricious and to move freely throughout the device.If the guidewire/device dries up and is not kept hydrated stickiness could ensue and the device may feel like it¿s not moving freely.The inner shaft was buckled in several locations.The stuck wire was confirmed due to the style of guidewire that was used during this procedure.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).
Event or Problem Description
It was reported that the delivery system was stuck on the wire.A 6 x 150 x 130 innova stent was selected for an endovascular treatment (evt) procedure.The 99% stenosed, focal target lesion was located in the moderately tortuous left superficial femoral artery (sfa).The innova stent was advanced ipsilateral over a.035 non-bsc wire.Dilatation was performed using a coyote balloon and sfa stenting was performed.After deploying the stent, the physician attempted to remove the innova delivery system but the system became stuck on the wire.The delivery system was removed together with the wire and the procedure was completed.There were no patient complications reported.

• Brand Name: INNOVA¿
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 7490784
• Report Number: 2134265-2018-03921
• Device Sequence Number: 333461
• Product Code: NIP
• UDI-Device Identifier: 08714729874041
• UDI-Public: 08714729874041
• Combination Product (Y/N): N
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2018

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: 01/18/2021
• Device Model Number: H74939293061530
• Device Catalogue Number: 39293-06153
• Device Lot Number: 21632241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Initial Date Received by Manufacturer: 04/17/2018
• Supplement Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 05/07/2018
• Supplement Report FDA Received Date: 05/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COYOTE BALLOON DILATATION CATHETER 4MM; RADIFOCUS ANGLE 0.035 GUIDEWIRE