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

Model Number	1550250-12
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned to abbott vascular 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.Based on the review of similar incidents there is no indication of a lot specific product quality issue.There was no damage noted to the sds during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.The investigation determined the reported failure to advance and stent dislodgement appear to be related to operational circumstances of the procedure.Based on the reported information, the stent delivery system (sds) encountered resistance with the moderately calcified, moderately tortuous anatomy causing the failure to advance.Manipulation against resistance likely resulted in the stent dislodgement from the sds during retraction.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was performed to treat a moderately calcified, moderately tortuous de novo proximal diagonal.The 2.50x12mm xience sierra failed to cross the lesion due to the anatomy and the stent dislodged.The stent remained partially attached to the delivery system and they were both removed as a single unit.A new same 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.

• 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: 10979079
• Report Number: 2024168-2020-10345
• Device Sequence Number: 4295550
• Product Code: NIQ
• UDI-Device Identifier: 08717648227080
• UDI-Public: 08717648227080
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/09/2020

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: 06/01/2021
• Device Model Number: 1550250-12
• Device Catalogue Number: 1550250-12
• Device Lot Number: 0052541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 12/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 126