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

Model Number	1550225-23
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a moderately tortuous, moderately calcified circumflex artery.A 2.25x23mm xience sierra stent delivery system (sds) failed to cross.During removal of the sds resistance was met with the unspecified guide liner and the stent dislodged.It is unclear whether the stent was being pulled back into the guide liner, or if the guide liner was being advanced over the stent.The stent was crushed into the vessel wall between the left main and circumflex with two additional xience sierra stents.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported stent dislodgement was confirmed.The reported failure to advance and difficult to remove could not be tested as it was based on operational circumstances.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 did not indicate a lot specific quality issue.The investigation determined the reported difficulties and subsequent treatment appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 12150070
• Report Number: 2024168-2021-05924
• Device Sequence Number: 11800948
• Product Code: NIQ
• UDI-Device Identifier: 08717648227035
• UDI-Public: 08717648227035
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/16/2022
• Device Model Number: 1550225-23
• Device Catalogue Number: 1550225-23
• Device Lot Number: 0110941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 07/12/2021
• Supplement Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR