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

Model Number	H74939200092020
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: around (b)(6).(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.No damage was noticed on the catheter shaft.The stent was not returned with the device.There is evidence that the stent was deployed by the customer site due to the pull handle being at it farthest travel.There is no indication that this device failed to function as designed.Inspection of the remainder of the device, revealed no other damage or irregularities.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).
Event or Problem Description
It was reported that the stent inadvertently deployed.A 9x20x120 epic vascular stent was selected for a procedure in the right superficial femoral artery (sfa).After the stent was opened and prepared, it was observed that the stent inadvertently partially deployed outside the patient.The procedure was completed with ballooning and went well.There were no patient complications and the patient was fine.

• Brand Name: EPIC¿ VASCULAR
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7210362
• Report Number: 2134265-2018-00113
• Device Sequence Number: 869203
• Product Code: NIO
• UDI-Device Identifier: 08714729805748
• UDI-Public: 08714729805748
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 01/02/2018

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: 09/14/2022
• Device Model Number: H74939200092020
• Device Catalogue Number: 39200-09202
• Device Lot Number: 21138605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2018
• Initial Report FDA Received Date: 01/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1