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

Catalog Number 1011709-23

Device Problems Leak/Splash (1354); Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577); Difficult to Advance (2920)

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

Event Date 06/29/2022

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.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 other incidents from this lot.It was reported that force was applied to the stent delivery system (sds) during removal of the device from the anatomy.It should be noted that the xience prime instructions for use states: applying excessive force to the delivery system can potentially result in loss or damage to the stent and/or delivery system components.The investigation determined the reported difficult to advance, difficult to remove, and the subsequent treatment appear to be related to the operational context of the procedure; however, a conclusive cause for the reported difficult or delayed activation, leak / splash, and material separation could not be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

It was reported that the procedure was to treat a de novo lesion in the right coronary artery (rca) with moderate calcification and heavy tortuosity.The 3.0x23mm xience prime stent delivery system (sds) had resistance during advancement due to the anatomy and was inflated 2-3 times at 12 atmospheres (atms) for one inflation and 15 atms for another inflation.The proximal shaft broke in two pieces while deploying the stent causing leakage of blood into the balloon and under deployment of stent.There was resistance with the anatomy during withdrawal and force was applied.The sds was simply withdrawn.The stent was partially deployed and ultimately deployed in the target lesion with additional dilatation.The device was soaked and the device was prepared (air aspiration) outside the anatomy prior to use.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: XIENCE PRIME 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: 15087340
• MDR Text Key: 296420446
• Report Number: 2024168-2022-08053
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IN
• 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: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1011709-23
• Device Lot Number: 2013141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2022
• 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