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

Model Number	1550350-18
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	06/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.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 moderately calcified lesion in the moderately tortuous distal right coronary artery (drca).During the procedure, the 3.5x18mm xience sierra drug eluting stent (des) was advanced towards the target lesion but could not cross the calcified anatomy.During withdrawal of the des from the anatomy, the stent was difficult to remove from the copilot and was noted to be crushed upon removal, possibly from the interaction with the anatomy.Another same size xience sierra 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 inspection was performed on the returned device.The reported material deformation was confirmed.The reported failure to advance could not be tested as it was based on operational circumstances.The reported difficult to remove could not be tested due to the condition of the returned device.Additionally, it was noted that the stent implant was returned dislodged from the balloon and the top portion of the guide wire exit notch was stretched.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.There was no damage noted to the device prior to use during preparation, which suggests a product quality issue did not contribute to the reported difficulties.In this case, it is likely the device interacted with the moderately calcified, moderately tortuous lesion during advancement resulting in the reported failure to advance and material deformation (stretched and mangled stent).Interaction with the copilot hemostatic valve (rhv) during retraction, as resistance was noted, likely contributed to the reported difficult to remove and noted stretched guide wire exit notch, ultimately causing the noted stent dislodgement.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.

• 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: 12189326
• Report Number: 2024168-2021-06179
• Device Sequence Number: 11110160
• Product Code: NIQ
• UDI-Device Identifier: 08717648227424
• UDI-Public: 08717648227424
• 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,Followup
• Report Date (Section B): 08/17/2021

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: 08/14/2022
• Device Model Number: 1550350-18
• Device Catalogue Number: 1550350-18
• Device Lot Number: 1020841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Initial Date Received by Manufacturer: 06/25/2021
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 08/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COPILOT; COPILOT
• Patient Age: 82 YR