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

Model Number	1550400-23
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/24/2021
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 identified no similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the guiding catheter during the attempted advancement causing the reported failure to advance and subsequent stent dislodgement.The dislodged stent was unable to be found; therefore, it is assumed a foreign body in the patient.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the 4.0x23 mm xience sierra stent delivery system (sds) was inserted to treat the right coronary artery, but it was unable to cross due to inadequate support from the guide catheter.The guide catheter was repositioned several times, but the sds was unable to cross.The sds was removed and replaced with another same size xience sierra, which was successfully implanted at the target.After removal of the first sds, it was noted that the stent was no longer on the sds.The patient was checked, but the stent was unable to be found on angiogram.The stent was also not found on the back prep table.During device prep, there was no resistance removing the protective sheath.The patient did not have any adverse symptoms related to the missing stent.The stent is thought to be inside the patient anatomy.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: 12532751
• Report Number: 2024168-2021-08603
• Device Sequence Number: 13738152
• Product Code: NIQ
• UDI-Device Identifier: 08717648227516
• UDI-Public: 08717648227516
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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): 09/27/2021

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: 03/08/2022
• Device Model Number: 1550400-23
• Device Catalogue Number: 1550400-23
• Device Lot Number: 0090441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 09/27/2021
• 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: Other