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

Catalog Number UNK XIENCE

Device Problem Migration (4003)

Patient Problem Embolism/Embolus (4438)

Event Date 02/01/2023

Event Type  Injury  

Event Description

It was reported that an unspecified xience stent had been implanted; however, now the stent was reported to be "loose" [migrated] and may have embolized.It is unknown if any treatment was performed.However, there was no clinically significant delay reported in the original procedure.No additional information was provided.

Manufacturer Narrative

Date of event estimated as (b)(6) 2023.Treatment/therapy start date estimated as (b)(6) 2023.Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated.Implant date estimated as (b)(6) 2023.The device was not returned for analysis.A review of the electronic lot history record (elhr) for this product was not performed because the part and lot numbers were not reported and the product was not returned for analysis.The reported patient effects of embolism is listed in the xience v everolimus eluting coronary stent systems instructions for use as a known patient effects of coronary stenting procedures.The investigation was unable to determine a conclusive cause for the reported stent "loose" [migration].Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.

• Brand Name: XIENCE 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: 16636916
• MDR Text Key: 312228781
• Report Number: 2024168-2023-03157
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK XIENCE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female