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

Model Number	H74939293061830
Medical Device Problem Codes	Fracture (1260); Occlusion Within Device (1423)
Health Effect - Clinical Codes	Reocclusion (1985); Claudication (2550)
Date of Event	11/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).Device evaluated by manufacturer: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
Same patient as mdr id # 2134265-2017-12568.It was reported that post the stent implant procedure that the patient experienced intermittent claudication and in-stent restenosis and a stent fracture were noted.(b)(6) 2017, the patient presented with intermittent claudication.During a lower extremity angiography it was observed that a 6 x 180 x 130 innova¿ stent that was implanted in (b)(6) 2017 had occluded.It was also confirmed that the innova¿ stent had fractured, in which it seems to be detached at 3 points.No treatment has been performed; however an endovascular treatment (evt) is scheduled next month.No further patient complications were reported.When the angiography from the implant procedure in (b)(6) 2017 was reviewed, it seemed the stent was deployed by pulling back on the innova delivery system.The physician stated the stent stretched as a result.The target lesion was 100% stenosed and was located in the mildly tortuous and moderately calcified left superficial femoral artery (sfa).A contralateral approach was achieved to reach the lesion and pre-dilation was performed.The procedure was completed with this device.No additional 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: 7101322
• Report Number: 2134265-2017-12021
• Device Sequence Number: 16452683
• Product Code: NIP
• UDI-Device Identifier: 08714729874058
• UDI-Public: 08714729874058
• 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
• Report Date (Section B): 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: H74939293061830
• Device Catalogue Number: 39293-06183
• Device Lot Number: 0019267183
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2017
• Initial Report FDA Received Date: 12/08/2017
• 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: GUIDE CATH: DESTINATION 6FR
• Outcome Attributed to Adverse Event: Other