MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE EPIC¿ VASCULAR; STENT, ILIAC

Model Number	H74939200068020
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	01/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: in her 70s.(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
Same case as mdr id# 2134265-2017-00764.It was reported that stent damage occurred.The target lesion was located in the right superficial femoral artery.An epic¿ vascular stent was advanced and implanted.The delivery system and guidewire were inadvertently removed together from the patient.A new wire was engaged and post-dilation was performed.The physician was not satisfied with the results and implanted a second epic¿ vascular distal to the first.Upon removal of the delivery system, the nosecone became stuck on the previously implanted stent, causing the implanted stent to elongate.The device was removed by disengaging the wheel lock on the handle and resheathing the deployment system.The second epic stent was post-dilated.It was noted that a vessel dissection had occurred.A non-bsc stent was deployed to cover both previously implanted stents.There were no further patient complications reported.

• Brand Name: EPIC¿ VASCULAR
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 6321670
• Report Number: 2134265-2017-00843
• Device Sequence Number: 11033134
• Product Code: NIO
• UDI-Device Identifier: 08714729805366
• UDI-Public: (01)08714729805366(17)20201031(10)18535083
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P110035
• 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): 01/19/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: H74939200068020
• Device Catalogue Number: 39200-06802
• Device Lot Number: 18535083
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2017
• Initial Report FDA Received Date: 02/10/2017
• 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 Weight: 82