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

Model Number	H74939293064070
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at the time of event: 18 years or older.(b)(4).Device evaluated by mfr:the complaint device was not received at the complaint investigation site (cis) for analysis.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
Event or Problem Description
It was reported that partial stent deployment occurred.The 99% stenosed, focal target lesion was located in the mildly tortuous and severely calcified superficial femoral artery (sfa).After passing through the 6f sheath, pre-dilation was performed and a 6 x 40 x 75 innova¿ stent was advanced ipsilateral femoral approach over the.014 guidewire and stent deployment was initiated.Severe resistance was felt when the thumbwheel was turned and the stent was only slightly deployed.The physician attempt to deploy any further and stent placement was stopped.The device was removed and the procedure was completed with a different device successfully.There were no patient complications reported and the patient¿s status post procedure was stable.

• 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: 7466740
• Report Number: 2134265-2018-03550
• Device Sequence Number: 160154
• Product Code: NIP
• UDI-Device Identifier: 08714729873631
• UDI-Public: 08714729873631
• 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): 04/07/2018

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: 10/01/2020
• Device Model Number: H74939293064070
• Device Catalogue Number: 39293-06407
• Device Lot Number: 21199886
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2018
• Initial Report FDA Received Date: 04/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1