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	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the circumflex coronary artery.A 3.5x38mm xience sierra stent delivery system (sds) failed to cross due to the anatomy.The sds was advanced against resistance further, then the sds felt resistance with the anatomy during removal when the stent dislodged within an unspecified guiding catheter.An unspecified 2x15mm balloon was advanced to inflate the stent against the guiding catheter and everything was removed together to successfully complete the procedure.There were no adverse patient sequelae and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned stent implant.The reported stent dislodgement 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 return device (catheter not returned).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 treatment appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: medical device problem code 2017 was 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: 12555378
• Report Number: 2024168-2021-08766
• Device Sequence Number: 11877201
• Product Code: NIQ
• UDI-Device Identifier: 08717648227462
• UDI-Public: 08717648227462
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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): 10/13/2021

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: 02/11/2022
• Device Model Number: 1550350-38
• Device Catalogue Number: 1550350-38
• Device Lot Number: 0073041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Initial Date Received by Manufacturer: 09/10/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 10/13/2021
• 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