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

Catalog Number UNK XIENCE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Death (1802); Myocardial Infarction (1969)

Event Date 12/18/2014

Event Type  Death  

Manufacturer Narrative

Date of death -estimated.Date of event - estimated.The unique device identifier (udi) is unknown because the part and lot numbers were not provided.Implant date - estimated.The devices were not returned for evaluation.A review of the lot history records 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 procedures.A conclusive cause for the reported deaths and the 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.The adverse patient events reported in the article and in are filed under a different medwatch mfr number.Literature title : percutaneous coronary intervention vs coronary artery bypass grafting in patients with left main coronary artery stenosis: a systematic review and meta-analysis.

Event Description

This is filed for the deaths.It was reported through a research article that xience stents may be related to death, myocardial infarction, target lesion revascularization, stroke, stent occlusion, and re-hospitalization.Specific patient information is unknown.Additional information can be found in the article "percutaneous coronary intervention vs coronary artery bypass grafting in patients with left main coronary artery stenosis: a systematic review and meta-analysis".Please see article for additional information.

• 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: 11389192
• MDR Text Key: 233946676
• Report Number: 2024168-2021-01527
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 65 YR