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

Model Number	H74939293062030
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that stent foreshortening occurred.Vascular access was obtained via an antegrade approach with a straight angle.The chronically total occluded target lesion was located in the mildly tortuous and severely calcified superficial femoral artery (sfa).The physician exposed the vessel and did an endarterectomy and patch graft first.After pre-dilation, a 6 mm-200 mm/130 cm innova stent was advanced to the target lesion.The thumbwheel was used with normal force until the white arrow was visible.Then the pull grip was used to deploy the stent.However, the stent was foreshortened, thus another non-bsc stent was placed overlapping the innova stent.The procedure was completed.No patient complications were reported and the patient¿s status was fine.

• 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: 6361496
• Report Number: 2134265-2017-01789
• Device Sequence Number: 744381
• Product Code: NIP
• UDI-Device Identifier: 08714729874065
• UDI-Public: (01)08714729874065(17)20181231(10)18733063
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/15/2017

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: 12/31/2018
• Device Model Number: H74939293062030
• Device Catalogue Number: 39293-06203
• Device Lot Number: 18733063
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2017
• Initial Report FDA Received Date: 02/27/2017
• 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: GUIDEWIRE: MAGIC TORQUE .035; INTRODUCER SHEATH: CORDIS 6FR
• Patient Age: 80 YR