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

Model Number	H74939293061830
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).
Event or Problem Description
It was reported that deployment difficulties were encountered.The 90% stenosed target lesion was located in a mildly calcified superficial femoral artery (sfa).Pre-dilation was performed with an unknown 4mmx22cm balloon catheter.A contralateral approached was used to introduce the 6 x180x130mm innova¿ stent and deployment was initiated via the thumbwheel.12cm of the innova¿ was deployed then the pull grip was attempted to be pulled to deploy the remainder of the stent.The pull grip malfunctioned and the remainder of the stent did not deploy.The physician attempted to use the pull grip over and over again and each time the innova¿ stent deployed little by little until the stent fully deployed.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of an innova self-expanding stent delivery system (sds).The outer shaft, mid-shaft, inner shaft, proximal liner and the remainder of the device were checked for damage.Visual examination showed a kink at the nosecone.There was one kink approximately 77.5cm from the nosecone on the outer sheath.A kink was noticed on the inner liner approximately 17.5 from the tip.The pull-rack was at is full travel.The stent was not returned in the device.The handle was opened to inspect for 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 difficulties were encountered.The 90% stenosed target lesion was located in a mildly calcified superficial femoral artery (sfa).Pre-dilation was performed with an unknown 4mmx22cm balloon catheter.A contralateral approached was used to introduce the 6 x180x130mm innova stent and deployment was initiated via the thumbwheel.12cm of the innova was deployed then the pull grip was attempted to be pulled to deploy the remainder of the stent.The pull grip malfunctioned and the remainder of the stent did not deploy.The physician attempted to use the pull grip over and over again and each time the innova stent deployed little by little until the stent fully deployed.No patient complications were 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: 6582529
• Report Number: 2134265-2017-04895
• Device Sequence Number: 90393
• Product Code: NIP
• UDI-Device Identifier: 08714729874058
• UDI-Public: (01)08714729874058(17)20190430(10)0019185696
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2017

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: H74939293061830
• Device Catalogue Number: 39293-06183
• Device Lot Number: 0019185696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/27/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2017
• Supplement Report FDA Received Date: 06/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1