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

Catalog Number 1011709-33

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

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

Event Date 02/11/2022

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 similar incidents from this lot. It was reported that negative pressure was held for 5 seconds prior to retracting into the guide catheter. It should be noted in the xience prime everolimus eluting coronary stent system (eecss), instructions for use (ifu) specifies: 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. It is unknown if the ifu deviation contributed to the reported event. 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.

Event Description

It was reported that the procedure was to treat a moderately calcified, heavily tortuous, de novo lesion in the left anterior descending (lad) artery. A 3x33mm xience prime drug eluting stent (des) was advanced to the target lesion and implanted without issue with one inflation at 10 atmospheres (atm). During removal, negative pressure was held for 5 seconds, however the balloon failed to deflate and was removed fully inflated from the anatomy with difficulty. There was no adverse patient effect and no clinically significant delay in the procedure. 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: 13811861
• MDR Text Key: 287585114
• Report Number: 2024168-2022-02840
• 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

• Type of Report: Initial
• Report Date: 03/17/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 1011709-33
• Device Lot Number: 1042141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial