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

Model Number	H74939200066020
Medical Device Problem Code	Difficult to Remove (1528)
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).
Event or Problem Description
Same case as mdr id# 2134265-2017-00843.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.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an epic self-expanding stent system.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.A kink was noticed on the inner shaft of the device approximately 5cm from the tip.The stent was not returned with the device.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.There was no evidence of any damage or irregularities contributing to the reported withdrawing difficulty, which could not be confirmed because the clinical circumstances could not be replicated.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.Bsc id (b)(4).
Event or Problem Description
Same case as mdr id# 2134265-2017-00843.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: 6321659
• Report Number: 2134265-2017-00764
• Device Sequence Number: 443343
• Product Code: NIO
• UDI-Device Identifier: 08714729805328
• UDI-Public: (01)08714729805328(17)20200311(10)19167444
• 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,Followup
• 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: 03/11/2020
• Device Model Number: H74939200066020
• Device Catalogue Number: 39200-06602
• Device Lot Number: 19167444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/19/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2017
• Supplement Report FDA Received Date: 03/07/2017
• 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