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

Model Number	H74939293061830
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).The device was not received for analysis.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
Event or Problem Description
It was reported that partial stent deployment occurred.The 100% stenosed, chronic total occluded (cto) target lesion was located in a mildly tortuous and severely calcified superficial femoral artery (sfa).The lesion was crossed subintimal with severe calcification.Pre-dilatation was performed using a 6mm mustang balloon catheter, but it had difficulty in crossing due to severe recoil and the angle of the iliac was steep.The 6x180x130 innova was advanced contralateral over a non-bsc.035¿ guidewire and stent deployment was initiated.Approximately mid-deployment, a sound was heard inside the handle like something broke, and further deployment was not possible.The physician disassembled the handle due to the suspected damage and released the stent using the pin and pull method.The stent was deployed successfully and post-dilated to complete the procedure.No patient complications were reported and the patient's condition was good post procedure.

• 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: 7007143
• Report Number: 2134265-2017-10624
• Device Sequence Number: 1157089
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 10/11/2017

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: 05/10/2020
• Device Model Number: H74939293061830
• Device Catalogue Number: 39293-06183
• Device Lot Number: 0020627806
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2017
• Initial Report FDA Received Date: 11/07/2017
• 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