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

Model Number	H74939293071530
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event 18 years or older.(b)(4).Device evaluation by manufacturer: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that deployment difficulty occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left superficial femoral artery.A 7x150x130 innova¿ stent was advanced contralaterally to the lesion and deployment was initiated via slight rotation of the thumb wheel, however high force was required to turn the wheel.After the thumb wheel was rotated, the physician deployed the stent using the pull grip and it was noted to be difficult; however, the stent was still able to be deployed with force.There were no patient complications reported in relation to this event.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of an innova self-expanding stent delivery system (sds) and no other devices.The outer shaft, middle shaft, inner shaft and the remainder of the device were checked for damage.The shaft showed a kink at the nosecone.There also was one kink on the inner shaft approximately 15cm from the tip.The pull handle was broken.The stent was not returned.The device was opened to find additional damage.No additional damage was noticed.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).
Event or Problem Description
It was reported that deployment difficulty occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left superficial femoral artery.A 7x150x130 innova¿ stent was advanced contralaterally to the lesion and deployment was initiated via slight rotation of the thumb wheel, however high force was required to turn the wheel.After the thumb wheel was rotated, the physician deployed the stent using the pull grip and it was noted to be difficult; however, the stent was still able to be deployed with force.There were no patient complications reported in relation to this event.

• 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: 6422793
• Report Number: 2134265-2017-02411
• Device Sequence Number: 16309388
• Product Code: NIP
• UDI-Device Identifier: 08714729874133
• UDI-Public: (01)08714729874133(17)20190430(10)0019200144
• Combination Product (Y/N): N
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2017

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: 04/30/2019
• Device Model Number: H74939293071530
• Device Catalogue Number: 39293-07153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/07/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2017
• Supplement Report FDA Received Date: 04/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1