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

Model Number	26926
Medical Device Problem Codes	Positioning Failure (1158); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that partial deployment and stent damage occurred.The 100% stenosed, focal target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery (sfa).Following pre-dilatation, a 6mm x15cm innova stent was advanced over a.014 wire and deployed in the distal sfa successfully.A 7mm x 15cm innova stent was then advanced ipsilateral and stent deployment was initiated.The thumbwheel suddenly stopped moving after the stent was deployed approximately half to two thirds.The pull grip was attempted to deploy the remainder of the stent but this was unsuccessful.The sheath was pushed and while the stent system was pushed and pulled repeatedly at the same time, the stent was able to deploy little by little until the stent was able to fully deploy.The placed stent was partially stretched and there were many areas not sufficiently dilated.A new wire and a new balloon were used to dilate the areas with insufficient dilatation.The procedure was completed and there were no patient complications reported.The patient was stable post procedure.
Event or Problem Description
It was reported that partial deployment and stent damage occurred.The 100% stenosed, focal target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery (sfa).Following pre-dilatation, a 6mm x15cm innova stent was advanced over a.014 wire and deployed in the distal sfa successfully.A 7mm x 15cm innova stent was then advanced ipsilateral and stent deployment was initiated.The thumbwheel suddenly stopped moving after the stent was deployed approximately half to two thirds.The pull grip was attempted to deploy the remainder of the stent but this was unsuccessful.The sheath was pushed and while the stent system was pushed and pulled repeatedly at the same time, the stent was able to deploy little by little until the stent was able to fully deploy.The placed stent was partially stretched and there were many areas not sufficiently dilated.A new wire and a new balloon were used to dilate the areas with insufficient dilatation.The procedure was completed and there were no patient complications reported.The patient was stable post procedure.Returned product consisted of an innova self-expanding stent system with a 0.014 guidewire.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.The guidewire that returned with the device appears to be stuck inside the device.The guidewire was pulled from both sides to see if it would come out.It did not move and the distal portion of the guidewire snapped when it was pulled.Visual examination revealed a kink at the nosecone.The handle appears to have been cracked open before because the top portion is slightly open.Microscopic examination did not reveal any additional damages and the stent did not return with the device.There is blood present in the inner liner and middle sheath.The device was x-rayed to see if any abnormalities could be found.The guidewire can be seen clearly and the proximal inner appears to have prolapsed.Operations engineering noted that even though the handle appears to have been possibly opened, if the proximal inner is prolapsed then that can cause the handle to be slightly opened.Handle gap proximal of thumbwheel is 2mm wide.They then proceeded to open the handle and confirmed that the proximal inner has prolapsed.They noted that the first teeth on the rack is damaged.They also noticed a blue mark on the inside of the handle from the rack rubbing against it.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the proximal inner is prolapsed which could cause difficulty to deploy.The innova dfu states: only advance the stent delivery system over an 0.035in guidewire.A stiff 0.035in guidewire is strongly recommended for deployment of the stent, especially for tortuous anatomy and contralateral approaches.Use of undersized guidewires may lead to insufficient support of the device which can compromise stent delivery.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/17/2018 08:09 am ct.The report number is being corrected from: 2134265-2018-64266to: 2134265-2018-63244.

• 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: 8135398
• Report Number: 2134265-2018-63244
• Device Sequence Number: 13514066
• Product Code: NIP
• UDI-Device Identifier: 08714729873778
• UDI-Public: 08714729873778
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2019

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: 02/28/2019
• Device Model Number: 26926
• Device Catalogue Number: 26926
• Device Lot Number: 0018935043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Initial Date Received by Manufacturer: 11/08/2018
• Supplement Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 12/05/2018
• Supplement Report FDA Received Date: 01/24/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: JUPITER GUIDEWIRE; JUPITER GUIDEWIRE; PARENT 6F SHEATH; PARENT 6F SHEATH; STERLING COYOTE BALLOON CATHETER; STERLING COYOTE BALLOON CATHETER