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

Model Number	H74939293074030
Medical Device Problem Codes	Bent (1059); Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr: 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
It was reported that the stent prematurely deployed and became damaged.The patient presented with a chronic total occluded (cto) lesion in the moderately tortuous and severely calcified left superficial femoral artery (sfa).Following pre-dilation, a 7 x 40 x 130 innova¿ was advanced contralateral however the stent delivery system (sds) was unable to pass through the ostium of the lesion.At that time, the distal stent began to prematurely deploy from the sds and the stent became slightly lifted.The stent remained in the sds and was removed from the patient.The procedure was completed with a different stent.There were no patient complications.

• 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: 7183346
• Report Number: 2134265-2017-13006
• Device Sequence Number: 122491
• Product Code: NIP
• UDI-Device Identifier: 08714729874089
• UDI-Public: 08714729874089
• 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): 12/13/2017

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: 08/31/2020
• Device Model Number: H74939293074030
• Device Catalogue Number: 39293-07403
• Device Lot Number: 0021084300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2017
• Initial Report FDA Received Date: 01/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1