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

Model Number	1550350-38
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.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 lesion located in the mid circumflex artery that was heavily calcified and 75% stenosed.The xience sierra stent delivery system was advanced to the lesion and during attempted deployment, the balloon would not inflate.Upon removal, without issue, it was noted that the shaft was bent.There was no reported adverse patient effect or a clinically significant delay in the procedure.A new xience sierra stent system was used to complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported activation failure and shaft bend was confirmed.Additionally, a guide wire notch tear was identified during return evaluation of the device.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 similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.It is likely handling and/or manipulation of the device during advancement and placement caused the noted guide wire notch tear, reported bent shaft and subsequent activation failure.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: medical device problem code 2889 - removed.

• 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: 12197013
• Report Number: 2024168-2021-06220
• Device Sequence Number: 3635166
• Product Code: NIQ
• UDI-Device Identifier: 08717648227462
• UDI-Public: 08717648227462
• 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): 08/27/2021

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: 04/25/2023
• Device Model Number: 1550350-38
• Device Catalogue Number: 1550350-38
• Device Lot Number: 1042041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Initial Date Received by Manufacturer: 06/29/2021
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1