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

Model Number	1125325-12
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	09/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of perforation is listed in the xience alpine, everolimus eluting coronary stent system (eecss), instructions for use (ifu) as a known patient effect of coronary stenting procedures.It was reported that the device was used in the left internal carotid artery petrous portion.The xience alpine everolimus eluting coronary stent system (eecss), domestic,ifu states: the xience alpine stent system is indicated for improving coronary artery luminal diameter in patients.In addition, the xience alpine stent system is indicated for treating de novo chronic total coronary occlusions.It is unknown if the ifu deviation contributed to the reported event.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined; however, the reported treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
Event or Problem Description
It was reported that during a left internal carotid artery stenting procedure, after successful implantation of the xience alpine stent, a perforation was noted.Two covered stents were successfully implanted, sealing the perforation.There was no adverse patient sequela.No additional information was provided.

• Brand Name: XIENCE ALPINE 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: 11244784
• Report Number: 2024168-2021-00684
• Device Sequence Number: 17058478
• Product Code: NIQ
• UDI-Device Identifier: 08717648199424
• UDI-Public: 08717648199424
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 01/28/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/22/2021
• Device Model Number: 1125325-12
• Device Catalogue Number: 1125325-12
• Device Lot Number: 8021441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 01/28/2021
• 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
• Patient Age: 73 YR
• Patient Weight: 83