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

Catalog Number 1120275-28

Device Problems Material Separation (1562); Failure to Advance (2524); Difficult to Advance (2920)

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

Event Date 04/25/2022

Event Type  malfunction  

Manufacturer Narrative

A visual and dimensional inspection was performed on the returned device.The noted material separation was confirmed.The reported failure to advance and difficult to advance/position could not be evaluated as the exact anatomical conditions encountered by the device and accessory devices used during the procedure could not be replicated in the test laboratory.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 reported failure to advance and difficult to advance/position appear to be related to the operational context of the procedure.However, the investigation was unable to determine a conclusive cause for the noted material separation.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

Event Description

It was reported that the procedure was to treat a heavily calcified, heavily tortuous anterior descending artery.The 2.75x28mm xience alpine stent delivery system (sds) was attempted to be advanced; however, failed to cross due to anatomy and resistance with unspecified device.There was no angioplasty performed.There was no adverse patient effects and no clinically significant delay in the procedure.Returned device analysis identified the hypotube was kinked 21.5 centimeters (cm) distal to the strain relief then separated 23cm distal to the strain relief.The fractured faces of the hypotube were in oval shape and jagged.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: 15348223
• MDR Text Key: 305584129
• Report Number: 2024168-2022-09341
• 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: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2022
• Device Catalogue Number: 1120275-28
• Device Lot Number: 9052941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2019
• 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 Sex: Male