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

Catalog Number 1011706-28

Device Problems Material Separation (1562); Failure to Advance (2524)

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

Event Date 06/22/2021

Event Type  malfunction  

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 did not indicate a lot specific quality issue. The investigation determined the reported difficulties appear to be related to circumstances of the procedure. There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device. The other stent delivery system referenced is filed under separate medwatch report number.

Event Description

It was reported that the procedure was to treat two heavily calcified lesions, one in the left circumflex (lcx) and the other in the left anterior descending (lad) coronary artery. Wires and balloons experienced difficulties accessing the lesions, but a few crossed and the lesions were able to be pre-dilated. A 2. 25x28mm xience prime drug eluting stent (des) was then advanced toward the lcx, and while attempting to push through the heavy calcification, the shaft of the des broke and separated into two pieces. The device was easily removed. The lesion was dilated again, but another des failed to cross the lesion. The lad was then pre-dilated lesion and a 2. 5x33mm xience prime des was advanced but the anatomy was too calcified to cross and the shaft separated into 2 pieces. The device was easily removed. The lesion was dilated again and the patient was referred for coronary artery bypass graft surgery. No additional information was provided.

• Brand Name: XIENCE PRIME SV 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: 12145129
• MDR Text Key: 261304903
• Report Number: 2024168-2021-05891
• 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: company representative,distri

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/09/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 1011706-28
• Device Lot Number: 0081041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No