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

Model Number	H74939293061030
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event 18 years or older.(b)(4).Device evaluated by manufacturer: an innova self-expanding stent delivery system was returned and the outer sheath, middle shaft and the remainder of the device were checked for damage.The shaft showed a kink at the nosecone.No additional damage was noticed.The stent was returned inside the device and it was inadvertently partially deployed approximately 12.5mm from the marker band.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Device analysis determined the condition of the returned device pertaining to the inadvertently deployed stent was consistent with the reported information.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 inadvertent stent deployment occurred.The target lesion was located in moderately calcified and mildly tortuous superficial femoral artery (sfa).A 6x100x130 innova¿ was introduced via a contralateral approach.Resistance was felt during advancement inside the 6f non bsc introducer sheath and the innova¿ was unable to pass through the sheath.During removal it was noticed that the innova¿ stent was slightly deployed.The procedure was completed with a different device and 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: 6518918
• Report Number: 2134265-2017-03788
• Device Sequence Number: 808238
• Product Code: NIP
• UDI-Device Identifier: 08714729874027
• UDI-Public: (01)08714729874027(17)20190131(10)18785728
• Combination Product (Y/N): N
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/03/2017

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: 01/31/2019
• Device Model Number: H74939293061030
• Device Catalogue Number: 39293-06103
• Device Lot Number: 18785728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2017
• Initial Report FDA Received Date: 04/25/2017
• 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: INTRODUCER SHEATH: TERUMO 6F 55CM