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

Model Number	1550225-12
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.Visual inspection was performed on the returned device.The reported difficult to remove was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation determined the reported difficult to remove appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.The bmw guidewire referenced is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the moderately calcified, distal right coronary artery.The balance middle weight (bmw) guide wire and the 2.25x12mm xience sierra stent delivery system (sds) successfully crossed the target lesion.The sierra stent was implanted without issue.However, resistance was felt with the guide wire during removal.The guidewire and the sds were removed together as a single unit.A burr could be felt on the radiopaque tip of the guide wire.There was no clinically significant delay in the procedure and no adverse patient effect.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: 10563565
• Report Number: 2024168-2020-07878
• Device Sequence Number: 13745074
• Product Code: NIQ
• UDI-Device Identifier: 08717648227004
• UDI-Public: 08717648227004
• Combination Product (Y/N): Y
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2020

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: 03/05/2021
• Device Model Number: 1550225-12
• Device Catalogue Number: 1550225-12
• Device Lot Number: 0022641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR