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

Model Number	1550300-12
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.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 heavily calcified left main to left anterior descending bifurcated lesion.After pre-dilatation with an nc balloon, a 3x12mm xience sierra was being advanced when the distal part of the stent got stuck on calcified plaque and the distal end of the stent implant started to deploy [flared struts].It was decided to simply withdraw the device.After several additional dilatations, another same size xience sierra stent was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual, functional and dimensional inspection was performed on the returned device.The reported material deformation 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 appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

• 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: 12182185
• Report Number: 2024168-2021-06147
• Device Sequence Number: 924804
• Product Code: NIQ
• UDI-Device Identifier: 08717648227240
• UDI-Public: 08717648227240
• Combination Product (Y/N): Y
• Initial Reporter State: PR
• 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): 08/06/2021

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: 03/14/2022
• Device Model Number: 1550300-12
• Device Catalogue Number: 1550300-12
• Device Lot Number: 103094A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Initial Date Received by Manufacturer: 06/25/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 07/16/2021
• Supplement Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR