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

Catalog Number 1070300-23

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

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

Event Date 09/29/2021

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a mildly calcified, mildly tortuous, 80% stenosed lesion in the left anterior descending (lad) artery. Resistance was met when advancing the 3. 0x23mm xience xpedition drug eluting stent (des) to the target lesion, and the des could not reach the target lesion. After the des was removed from the anatomy, the shaft of the delivery system was noted to be separated into two pieces. There was no adverse patient effect and no clinically significant delay in the procedure. Another same size des was used to successfully complete the procedure. No additional information was provided.

• Brand Name: XIENCE XPEDITION 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: 13362217
• Report Number: 2024168-2022-00891
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• 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,Followup
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 1070300-23
• Device Lot Number: 1042941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sex: No Answer Provided
• Patient Weight: KG