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

Model Number	1550300-38
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation determined the reported difficulties and subsequent treatment appear to be related to the operational context 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 the procedure was to treat a heavily calcified, heavily tortuous lesion in the mid left anterior descending artery (lad).Resistance was felt with the anatomy, during advancement of the 3.0x38 mm xience sierra stent delivery system (sds) to the target lesion.The stent dislodged from the balloon at the target lesion.The delivery system was removed without issue.A new balloon was used to expand the dislodged stent to the vessel wall at the target lesion.There were no adverse patient effects and no clinically significant delay during 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: 11788105
• Report Number: 2024168-2021-03884
• Device Sequence Number: 19716780
• Product Code: NIQ
• UDI-Device Identifier: 08717648227301
• UDI-Public: 08717648227301
• 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
• Device Implanted Year: 2021
• 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): 05/06/2021

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: 07/05/2022
• Device Model Number: 1550300-38
• Device Catalogue Number: 1550300-38
• Device Lot Number: 0122141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 05/06/2021
• 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