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

Catalog Number UNK RX PRIME

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

Patient Problems Death (1802); Myocardial Infarction (1969); Thrombosis/Thrombus (4440)

Event Date 08/01/2007

Event Type  Death  

Manufacturer Narrative

Outcomes to adverse event/date of event/implant date: dates estimated.The adverse patient effects referenced will be filed under a separate medwatch report #.The additional device referenced in is being filed under a separate medwatch report #.The device was not returned for evaluation.A review of the lot history record of the reported lot could not be conducted because the part and lot number were not provided.The reported patient effect of death is listed in the xience prime, xience prime sv, and xience prime ll everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary procedures.A conclusive cause for the reported death and the relationship to the product, if any, cannot be determined.The treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.The udi is unknown as the part and lot numbers were not provided.Article title: differential cutoff points and clinical impact of stent parameters of various drug-eluting stents for predicting major adverse clinical events: an individual patient data pooled analysis of seven stent-specific registries and 17,068 patients na.

Event Description

It was reported through a research article identifying xience prime and xience v that may be related to the following: patient death, thrombosis, myocardial infarction, revascularization, and rehospitalization.This article summarizes clinical outcomes of 1,934 patients that were treated with xience prime stents and 3,053 patients that were treated with xience v stents.Specific patient information is documented as unknown.Details are listed in the attached article, titled "differential cutoff points and clinical impact of stent parameters of various drug-eluting stents for predicting major adverse clinical events: an individual patient data pooled analysis of seven stent-specific registries and 17,068 patients.".

• Brand Name: XIENCE PRIME 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: 11373474
• MDR Text Key: 233407139
• Report Number: 2024168-2021-01425
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: KS
• PMA/PMN Number: P110019
• 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: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK RX PRIME
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death