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

Model Number	H74939200066020
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: over 70 (b)(4).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.The inner shaft was completely detached from the device.The handle was opened up to analyze the components and the inner bond.Microscopic inspection of the handle components and inner shaft revealed that the inner shaft was appropriately bonded to the female luer.The inner shaft had 3mm of residual adhesive on the proximal end.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.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.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 a hypotube dislodgement occurred.The target lesion was located in the superficial femoral artery.The 6x60x120 epic¿ vascular stent was deployed over an unspecified.035 wire.The stent deployed fine.Upon removal of the delivery system, it was noticed that the inner hypotube had come dislodged off of the delivery system.Everything was removed out from the patient.There were no patient complications and the patient's condition was fine.

• 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: 6503618
• Report Number: 2134265-2017-03736
• Device Sequence Number: 16146179
• Product Code: NIO
• UDI-Device Identifier: 08714729805328
• UDI-Public: (01)08714729805328(17)20190819(10)20103143
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P110035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/31/2017

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: 08/19/2019
• Device Model Number: H74939200066020
• Device Catalogue Number: 39200-06602
• Device Lot Number: 20103143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2017
• Initial Report FDA Received Date: 04/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1