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

Catalog Number 1011711-38

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)

Patient Problem Insufficient Information (4580)

Event Date 03/09/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 other incidents from this lot.It should be noted that the xience prime ll everolimus eluting coronary stent system instructions for use (ifu) states: deflate the balloon by pulling negative on the inflation device.Larger and longer balloons will take more time (up to 30 seconds) to deflate than smaller and shorter balloons.Confirm balloon deflation under fluoroscopy and wait 10 ¿ 15 seconds longer.After successful withdrawal of the balloon from the deployed stent, should any resistance be felt at any time when withdrawing the stent delivery system into the guide catheter, remove the entire system as a single unit.Failure to follow these steps and / or 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 difficulties appear to be related to deviation of the ifu and subsequent circumstances of the procedure as it is likely that a sufficient time was not allowed to fully deflate the balloon resulting in compromising the inflation /deflation lumen thus resulting in the reported deflation problem and the reported difficult to remove as the partially deflated balloon got stuck at the tip of the procedural sheath.Manipulation of the device ultimately resulted in the reported material separation.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 the 75% stenosed superficial femoral artery.Pre-dilatation was performed and the 4.0x38 mm xience prime stent was deployed; however, the physician did not allow the appropriate time for deflation of the balloon.Resistance was met during removal of the stent delivery system (sds) and the partially deflated balloon got stuck at the tip of the procedural sheath.The sds was then pulled with excessive force and the distal portion of the balloon separated and remained on the guide wire still in the patient.The guide wire was removed with the separated portion of the balloon and there were no effects to the patient.There was no reported clinically significant delay in the procedure.The physician acknowledged that there was no device issue and that the problem was due to user error of not letting the balloon deflate fully.Three other xience prime stents were implanted in the same patient without issue.No additional information was provided.

• Brand Name: XIENCE PRIME LL 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: 11602736
• MDR Text Key: 244393312
• Report Number: 2024168-2021-02614
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: AS
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2023
• Device Catalogue Number: 1011711-38
• Device Lot Number: 0051342
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2021
• Initial Date FDA Received: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1