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

Model Number	1550250-38
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.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 other incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.Interaction with the anatomy/other devices and/or manipulation of the device ultimately resulted in the reported stent dislodgement.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that this was a percutaneous procedure to treat a coronary artery.The xience sierra was inserted, but was unable to cross the vessel due to the moderately calcified patient anatomy.After removal of the xience sierra delivery system, the stent was no longer on the balloon, but remained on the delivery system.Another same size xience sierra was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.There was no additional information 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: 10583830
• Report Number: 2024168-2020-08003
• Device Sequence Number: 13763315
• Product Code: NIQ
• UDI-Device Identifier: 08717648227141
• UDI-Public: 08717648227141
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• 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): 09/24/2020

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: 05/20/2021
• Device Model Number: 1550250-38
• Device Catalogue Number: 1550250-38
• Device Lot Number: 0051541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/04/2020
• Initial Report FDA Received Date: 09/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1