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 Myocardial Infarction (1969); Perforation of Vessels (2135); Stenosis (2263); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 01/01/2007

Event Type  Injury  

Manufacturer Narrative

Age or date of birth: mean age.Sex: majority gender.Date of event, implant date: estimated date.The unique device identifier (udi) is ¿ni¿ because the part number was not provided the device was not returned for analysis.A review of the lot history record for this product was not performed as the part and lot numbers were not reported and the product was not returned for analysis.It should be noted that the reported patient effect(s) of occlusion, perforation, myocardial infarction, thrombosis, and stenosis are listed in the xience v everolimus eluting coronary stent systems instructions for use as a known patient effect(s) of coronary stenting procedures.A conclusive cause for the reported patient effect(s), 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.The additional patient deaths, effects and xience sierra devices reported in the pmcf report are captured under separate medwatch report numbers.Post-market clinical follow-up (pmcf) report titled ¿xience sierra everolimus-eluting coronary stent system ¿ small size¿.

Event Description

The post-market clinical follow-up (pmcf) report, titled ¿xience sierra everolimus-eluting coronary stent system ¿ small size¿, evaluated the safety and performance of xience sierra in a cohort of real-world patients receiving xience sierra small diameter stent.Data was collected on 133,034 patients and procedures.1,846 patients received small diameter stents, and of these 178 patients received small diameter xience sierra.The other patients received either xience family stent, or approved competitors.The competitors included biosensors biomatrix, biotronik orsiro, bs promus, bs promus element, bs promus element plus, bs promus elite, bs promus premier, bs synergy, medtronic endeavor resolute, medtronic resolute integrity, medtronic resolute onyx, and terumo ultimaster.It was also reported through a post-market clinical follow-up (pmcf) report that the xience stent family may be related to side-branch closures, perforation, acute coronary artery bypass graft (cabg), myocardial infarction, target lesion revascularization, stent thrombosis.Although the above adverse events were noted, in conclusion, the overall analyses from this study demonstrates that the use of small size xience sierra stent in a real-world, high-risk population is associated with periprocedural safety and performance outcomes and outcomes out to 1 year that are similar to other contemporary small size drug eluting stent (des) and any size des and xience family of devices.Specific patient information is documented as unknown.Details are listed in the pmcf report titled ¿xience sierra everolimus-eluting coronary stent system ¿ small size¿.

• 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: 12647744
• MDR Text Key: 276891740
• Report Number: 2024168-2021-09307
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: SW
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• 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: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 68 YR