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

Model Number	1550350-23
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	04/30/2021
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 did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that resistance was met with the mildly calcified and severely tortuous anatomy resulting in the reported failure to advance and the difficult to remove.Interaction with the mildly calcified and severely tortuous anatomy and/or manipulation of the device resulted in the reported material deformation.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional xience sierra referenced is filed under a separate medwatch report number.
Event or Problem Description
It was reported that this was a procedure to treat a lesion with mild calcification and severe tortuosity in the right coronary artery (rca).The first xience sierra stent delivery system (sds) was advanced but could not cross the lesion due to the severe tortuosity.When the sds was removed there was difficulty and the proximal end of the stent became flared.A second xience sierra was advanced but could not cross the lesion due to the tortuosity.The second sds had the same issue during removal and the stent proximal end of the stent became flared too.The physician decided to abort the procedure as nothing could cross the lesion.There was no adverse patient effect and no clinically significant delay in the procedure.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: 11886708
• Report Number: 2024168-2021-04424
• Device Sequence Number: 13769575
• Product Code: NIQ
• UDI-Device Identifier: 08717648227431
• UDI-Public: 08717648227431
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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
• Report Date (Section B): 05/26/2021

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: 07/24/2022
• Device Model Number: 1550350-23
• Device Catalogue Number: 1550350-23
• Device Lot Number: 1011941
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1