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

Model Number	1145275-12
Medical Device Problem Codes	Material Rupture (1546); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a moderately calcified, 80% stenosed lesion in the obtuse marginal (om).The vessel was pre-dilatated with an unspecified nc trek balloon dilatation catheter (bdc), and a 2.75x12mm xience alpine drug eluting stent (des) was advanced to the target lesion.Once at the lesion, the des was inflated one time to 7 atmospheres (atm) when the balloon ruptured.The des remained in place and the stent was partially deployed in the target lesion.A new nc trek bdc was used to complete the deployment of the stent which completed the procedure.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
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.A conclusive cause for the reported difficulties cannot be determined; however, the subsequent 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.B5: case description was updated.

• Brand Name: XIENCE ALPINE OTW 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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16584707
• Report Number: 2024168-2023-02921
• Device Sequence Number: 14627065
• Product Code: NIQ
• UDI-Device Identifier: 08717648199967
• UDI-Public: 08717648199967
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2023

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: 08/23/2024
• Device Model Number: 1145275-12
• Device Catalogue Number: 1145275-12
• Device Lot Number: 1081841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/27/2023
• Supplement Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown