MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Model Number	1550350-28
Medical Device Problem Codes	Difficult to Insert (1316); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and visual, dimensional and functional inspections were performed.The reported difficulty to insert the guide wire was confirmed.Additionally, it was noted that the outer and inner member was stretched.A review of the lot history record identified no manufacturing non-conformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents and/or complaints reported from this lot.The investigation determined the reported difficult to insert the guide wire appears to be related to operational circumstances of the procedure.It is likely that during sheath removal and/or device preparation, the stent delivery system was inadvertently stretched at the guide wire notch area (inner and outer member) resulting in the difficulty to insert or advance the guide wire.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the 3.5x28mm xience sierra stent delivery system (sds) was prepared for use but was unable to load onto the 0.014 inch guidewire; therefore, the device was not used.There was no patient involvement and no clinically significant delay in the procedure.Return analysis noted the shaft was stretched.No additional information was provided.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10020661
• Report Number: 2024168-2020-04056
• Device Sequence Number: 16923383
• Product Code: NIQ
• UDI-Device Identifier: 08717648227448
• UDI-Public: 08717648227448
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/04/2020

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: 05/29/2022
• Device Model Number: 1550350-28
• Device Catalogue Number: 1550350-28
• Device Lot Number: 9052541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2020
• Initial Report FDA Received Date: 05/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1