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

Catalog Number 1120400-18

Device Problems Leak/Splash (1354); Product Quality Problem (1506); Activation Failure (3270)

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

Event Date 03/18/2022

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a moderately calcified, moderately tortuous lesion in the left circumflex (cx) artery.A 4x18mm xience alpine drug eluting stent (des) was advanced to the target lesion, however, the delivery system balloon failed to inflate, and the stent could not be implanted.The des was removed with the unimplanted stent, and it was noted that there was unknown damage to the shaft of the device.There was no adverse patient effect and no clinically significant delay in the procedure.Another xience alpine was used to successfully complete the procedure.No additional information was provided.

Manufacturer Narrative

Visual and functional inspections were performed on the returned device.The reported stent expansion failure could not be tested due to device condition.The reported leak/splash and product quality problem were confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Na.

Event Description

Subsequent to the initial filed report, the following information was received: a leak was noted from the device during use in the patient.

• 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: 14074977
• MDR Text Key: 289601481
• Report Number: 2024168-2022-03863
• 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: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1120400-18
• Device Lot Number: 1040941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2021
• 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 Age: 61 YR
• Patient Sex: Male
• Patient Weight: 88 KG