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

Model Number	1550300-08
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported this was a procedure to treat a moderately calcified and moderately tortuous left circumflex.A 3.0x8mm xience sierra drug eluting stent (des) was inserted.However, prior to reaching the lesion, heavy resistance was felt.Therefore, the physician decided to remove the device.It was noted that due to the anatomy, resistance was felt during removal.Once removed, no device damage was observed.A new device was inserted, and the procedure was successfully performed.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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 was unable to determine a conclusive cause for the reported failure to advance.Additionally, the reported difficult to remove appears to be related to circumstances of the procedure as it is likely the device interacted with the moderately calcified and moderately tortuous lesion causing the reported difficulty to remove.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: 12422689
• Report Number: 2024168-2021-07874
• Device Sequence Number: 3420831
• Product Code: NIQ
• UDI-Device Identifier: 08717648227233
• UDI-Public: 08717648227233
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2021

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: 10/21/2021
• Device Model Number: 1550300-08
• Device Catalogue Number: 1550300-08
• Device Lot Number: 810174A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/19/2021
• Supplement Date Received by Manufacturer: 09/03/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1