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

Catalog Number 1070350-12

Device Problem Material Separation (1562)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 09/29/2020

Event Type  Injury  

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 identified no similar incidents from this lot. The investigation was unable to determine a conclusive cause for the reported material separation/stent break; however, the subsequent treatments 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.

Event Description

It was reported that the procedure was to treat a moderately tortuous, heavily calcified right coronary artery (rca). During an implantation of a 3. 5x38mm xience xpedition stent, the struts of the stent became separated. The stent was crushed into the vessel and another xience xpedition was used to successfully complete the procedure. There was no clinically significant delay. 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: 10742121
• MDR Text Key: 213382259
• Report Number: 2024168-2020-08936
• 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: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/03/2022
• Device Catalogue Number: 1070350-12
• Device Lot Number: 9022741
• 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: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 10/27/2020 Patient Sequence Number: 1