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

Catalog Number UNK XIENCE V

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Stroke/CVA (1770); Myocardial Infarction (1969); Stenosis (2263); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446)

Event Date 10/01/2020

Event Type  Death  

Event Description

This is filed to report patient deaths.It was reported through a research article that the following adverse events may be related to the xience v stent: death, thrombus, stenosis, myocardial infarction, stroke, heart failure.Additionally, there may have been cases of poor wall apposition.The article concludes that the total incidence of adverse cardiovascular events was 26.47% in the non-abbott stent group and 20.00% in the xience v stent group.There is no difference in the probability of in-stent restenosis and the rate of stent apposition is better in the xience v group.

Manufacturer Narrative

Date of death - estimated.Date of event ¿ estimated.Treatment/therapy start date - estimated.The unique device identifier (udi) is unknown because the part number and lot number were not provided.Date of implant ¿ estimated.The device was not returned for evaluation.A review of the lot history record and complaint history could not be conducted because the part and lot numbers were not provided.The reported patient effect of death is listed in the xience v everolimus eluting coronary stent systems instructions for use (ifu) as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient-device incompatibility, and death, and their relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Literature: comparison and evaluation of the advantages and disadvantages of domestic stent helios and imported stent abbott through optical coherence tomography system.The other patient effects reported in the article are captured under a separate medwatch report.

• 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: 14961513
• MDR Text Key: 295594867
• Report Number: 2024168-2022-07406
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK XIENCE V
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2022
• 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): Death