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

Catalog Number 1120250-23

Device Problems Break (1069); Failure to Advance (2524); Deformation Due to Compressive Stress (2889)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/10/2021

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The additional xience alpine is filed under a separate medwatch report number.

Event Description

It was reported that the procedure was to treat a heavily calcified, heavily tortuous left anterior descending artery.Two xience alpine stent delivery systems (2.5x23mm and 2.75x33mm) failed to cross and both shafts on each device were noted to be "fractional" (break) and kinked.Another unspecified stent was used to successfully complete the procedure.There was no adverse patient effects reported and no clinically significant delay reported.No additional information was provided.

Manufacturer Narrative

A visual and dimensional inspection was performed on the returned device.The reported shaft break was not confirmed.The reported deformation due to compressive stress was confirmed.The reported failure to advance could not be tested as it was based on operational circumstances.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 failure to advance and deformation due to compressive stress appear to be related to circumstances of the procedure.The investigation was unable to determine a conclusive cause for the reported shaft break.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 13169462
• MDR Text Key: 284192896
• Report Number: 2024168-2022-00083
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: EG
• 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,Followup
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2022
• Device Catalogue Number: 1120250-23
• Device Lot Number: 9040841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2019
• 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 Age: 71 YR
• Patient Sex: Male
• Patient Weight: 88 KG