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

Model Number	1550225-18
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	02/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified lesion in the mid/proximal left anterior descending (lad) coronary artery.A previously implanted stent was also present in the proximal lad.The 2.25x18 mm xience sierra stent delivery system (sds) could not cross to treat the lesion due to the anatomy and during removal there was resistance with the lesion and the previously implanted stent.While removing the sds from the anatomy, a dissection was caused.Another unspecified stent was attempted to be deployed to cover the dissection but was unsuccessful so the patient was sent to surgery.The final patient outcome is good.No additional information was provided.
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned device.The reported failure to advance and difficult to remove could not be tested as they were 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 reported patient effect of dissection is listed in the xience sierra, everolimus eluting coronary stent system, instructions for use as a known patient effect of coronary stenting procedures.The reported difficulties and subsequent treatments appear to be related to the circumstances of the procedure.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.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: 11440562
• Report Number: 2024168-2021-01838
• Device Sequence Number: 3776641
• Product Code: NIQ
• UDI-Device Identifier: 08717648227028
• UDI-Public: 08717648227028
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 03/31/2021

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: 05/10/2021
• Device Model Number: 1550225-18
• Device Catalogue Number: 1550225-18
• Device Lot Number: 0050141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 03/31/2021
• 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: 83 YR