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

Catalog Number 1120350-23

Device Problems Inflation Problem (1310); Leak/Splash (1354); Device Dislodged or Dislocated (2923)

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

Event Date 05/24/2022

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a 95% stenosed lesion.A 3.5x23mm xience alpine drug eluting stent (des) was advanced to the target lesion; however, the balloon only partially inflated.Several attempts were made to inflate the balloon, but only the distal 2/3 of the stent expanded.The stent dislodged from the balloon at the target lesion and was able to be snared and removed from the anatomy.There was no adverse patient sequela or a clinically significant delay in the procedure.No additional information was provided.

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.The investigation was unable to determine a conclusive cause for the reported difficulties; however, the subsequent treatment appears to be related to the operational context of the procedure.Additionally, the reported removal of a foreign body was due to a dislodged stent within the anatomy.Factors that may contribute to a dislodged stent include, but are not limited to, improper or inadequate crimping at the time of manufacture, handling of the stent during preparation, interaction with challenging anatomy, and/or interaction with accessory devices.Factors that may contribute to a leak include, but are not limited to, damage to the inflation lumen, loose connection with the indeflator, and/or damage to the balloon.Factors that may contribute to an inflation problem include, but are not limited to, anatomical morphology, loose connection with the indeflator, contamination in the inflation lumen, and/or damage to the inflation lumen.In this case, it is possible that the stent delivery system (sds) interacted with the 95% stenosed anatomy and/or accessory devices during advancement, resulting in the reported leak and subsequently contributed to the reported inflation problem.Additionally, it is possible the failed inflation and/or interaction with the challenging anatomy contributed to the reported stent dislodgement; however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

Subsequent to the initial filed report, the following information was received: it was reported that the procedure was to treat an unknown, 95% stenosed lesion.A 3.5x23mm xience alpine drug eluting stent (des) was advanced to the target lesion, however the balloon only partially inflated, and stent detached from the balloon at the target lesion.The stent was snared from the anatomy.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: 14782086
• MDR Text Key: 294954640
• Report Number: 2024168-2022-06734
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: AR
• 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: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1120350-23
• Device Lot Number: 1090241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2021
• 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): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 75 KG