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

Catalog Number UNK XIENCE

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problem Stenosis (2263)

Event Date 07/12/2021

Event Type  Injury  

Manufacturer Narrative

Date of event, implant date: estimated dates.Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated.The stent remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.

Event Description

It was reported that restenosis was found in an unspecified xience stent.No additional information was provided.

Event Description

Subsequent to the initial report, the following information was received: the restenosis found was in a non-abbott stent.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the electronic lot history record (elhr) and a similar incident query for this product was not performed because the part and lot numbers were not reported and the product was not returned for analysis.An investigation was not conducted because there were no specific reported device malfunction or patient effect associated with the device.There is no indication of a product quality issue with respect to design, manufacture or labeling.B5: describe event or problem.H6: medical device problem code 2993 - removed health effect - clinical code 2263 - removed.

• 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
• MDR Report Key: 12281764
• MDR Text Key: 265195574
• Report Number: 2024168-2021-06853
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK XIENCE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other