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

Model Number	1550350-23
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2021
Type of Reportable Event	Serious Injury
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 did not indicate a lot specific quality issue.The investigation determined the reported difficulties and subsequent treatments appear to be related to circumstances of the procedure.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 to treat a heavily calcified and tortuous lesion in the circumflex (cx).Outside of the patient the 3.50x23mm rx xience sierra stent delivery system (sds) was being advanced over the non-abbott guide wire when resistance was met and the sds became stuck.Hemostats were needed to remove the sds from the guide wire.Per the physician, the guide wire was not properly wetted prior to advancement of the sds.A second 3.50x23mm rx xience sierra sds was advanced into the patient however met resistance when attempting to advance through the open cell of the previously implanted non-abbott stent.The sds was pushed forward however the stent came off the balloon.The sds was removed and a snare device was used to retrieve the dislodged stent.The procedure was aborted at this time with no further treatment performed.There was no clinically significant delay in the procedure and no adverse patient effects.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: 11608175
• Report Number: 2024168-2021-02675
• Device Sequence Number: 19807704
• Product Code: NIQ
• UDI-Device Identifier: 08717648227431
• UDI-Public: 08717648227431
• 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
• Report Date (Section B): 04/02/2021

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: 02/18/2022
• Device Model Number: 1550350-23
• Device Catalogue Number: 1550350-23
• Device Lot Number: 0081041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 04/02/2021
• 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: NON-ABBOTT IMPLANTED STENT
• Outcome Attributed to Adverse Event: Required Intervention