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

Model Number	H74939293066030
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Thrombosis (2100); Claudication (2550)
Date of Event	02/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 thrombosis and a stent fracture occurred.A 6x60x130 innova¿ stent was selected for a procedure on (b)(6) 2017.On (b)(6) 2018, the patient presented with left leg claudication.Thrombosis was observed in the previously placed stent in the left leg.It was noted that the stent was fractured.The patient was treated with angioplasty, arthrectomy and a new innova stent was placed inside the current innova stent.There were no further patient complications reported and the patient's condition post procedure was stable.

• 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: 7338978
• Report Number: 2134265-2018-01825
• Device Sequence Number: 1092638
• Product Code: NIP
• UDI-Device Identifier: 08714729874003
• UDI-Public: 08714729874003
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 02/21/2018

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: 03/31/2020
• Device Model Number: H74939293066030
• Device Catalogue Number: 39293-06603
• Device Lot Number: 0020461569
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2018
• Initial Report FDA Received Date: 03/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR