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

Model Number	H74939293061830
Medical Device Problem Codes	Stretched (1601); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2017
Type of Reportable Event	Malfunction
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
It was reported that partial stent deployment and stent damage occurred.The 80% stenosed target lesion was located in the severely tortuous and severely calcified superficial femoral artery.Vascular access was gained via the left brachial artery.A 6f 90cm non bsc introducer sheath was advanced and balloon angioplasty was performed with a 4mm non bsc balloon catheter.The innova¿ 6x180x130 stent was then advanced over a.014¿ 300cm non bsc guidewire.Deployment of the innova¿ was initiated via the thumbwheel and the pullgrip was pulled to deploy the remainder of the stent.It was noted that about 3cm of the stent remained within the sheath.The stent delivery system was then removed resulting in stretching the proximal side of the stent about 4-5cm.Blood flow was secured, no patient complications were reported and the procedure concluded.

• 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: 7095517
• Report Number: 2134265-2017-11824
• Device Sequence Number: 19061702
• 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,distri
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 11/13/2017

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: 05/03/2020
• Device Model Number: H74939293061830
• Device Catalogue Number: 39293-06183
• Device Lot Number: 0020602686
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 92169170-FA
• Patient Sequence Number: 1
• Patient Weight: 55