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

Catalog Number 1120225-23

Device Problems Failure to Advance (2524); Difficult to Advance (2920)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 10/17/2022

Event Type  Injury  

Manufacturer Narrative

A visual and dimensional inspection was performed on the returned device.The reported difficult to advance and failure to advance could not be tested as it was based on operational context.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 of the reported lot 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.Additionally, a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.In this case, it is likely that the stent delivery system interacted with the patient¿s heavily calcified, mildly tortuous, and 90% stenosed lesion during advancement, as resistance was noted, resulting in the reported difficult to advance and subsequent failure to advance.Manipulation of the device during its interaction with the anatomy likely resulted in the flared stent and wrinkled balloon noted during return analysis.There is no indication of a product quality issue with respect to manufacture, design, or labeling of the device.

Event Description

It was reported that the procedure was to treat a heavily calcified, mildly tortuous, de novo left anterior descending artery that was 90% stenosed.A 2.25x23mm xience alpine failed to cross due to anatomy and another unspecified device.A non-abbott device was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.Device analysis noted that there was biological material noted at the flared struts.No additional information was provided.

• Brand Name: XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: 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: 16311201
• MDR Text Key: 308927864
• Report Number: 2024168-2023-01253
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1120225-23
• Device Lot Number: 1082041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female