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 Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969)

Event Date 01/01/2015

Event Type  Injury  

Manufacturer Narrative

B3: the date of procedure will be estimated as (b)(6) 2013.D4: the udi is unknown because the part number and lot number were not provided.The device was not returned for analysis.A corrective and preventive actions (capa) review was performed and revealed no indication of a product quality issue.A review of the electronic lot history record (elhr) and a lot level similar incident review 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 stroke, myocardial infarction, and hemorrhage are listed in the xience prime everolimus eluting coronary stent systems instructions for use as a known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however, the subsequent 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.

Event Description

It was reported through an article identifying that the xience v and xience prime stents maybe be related to the following: cardiac death, myocardial infarction, total coronary revascularization, stroke, and bleeding.The article summarizes outcomes of 7712 patients wherein 4882 underwent complex percutaneous coronary intervention (cpci).Cpci was compared with non-cpci.The effect of biodegradable polymer drug-eluting stents (bp-des) compared with durable polymer drug-eluting stents (dp-des) on outcomes was similar in cpci and non-cpci patients at 2 years but had inconsistent effects at the 5-year clinical endpoints.Details are listed in the article titled, 'five-year outcomes of biodegradable versus second-generation durable polymer drug-eluting stents used in complex percutaneous coronary intervention'.

• 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: 19210241
• MDR Text Key: 341353884
• Report Number: 2024168-2024-05256
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• 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: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• 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: 04/17/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization; Disability; Other; Required Intervention