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 Problems Patient-Device Incompatibility (2682); Material Deformation (2976)

Patient Problems Occlusion (1984); Thrombosis (2100); Stenosis (2263)

Event Date 11/01/2010

Event Type  Injury  

Manufacturer Narrative

Event estimated dates.Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated.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 number were not provided.The investigation determined a conclusive cause for the reported patient-device incompatibility wall apposition and material deformation cannot be determined.The reported patient effects of stenosis, thrombosis and occlusion are listed in the xience prime everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported stenosis, thrombosis and occlusion, and the relationship to the product, if any, cannot be determined.The treatment(s) appear 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 xience v/promus, xience prime sv and xience xpedition sv devices are being filed under separate medwatch report numbers.Literature titled "impact of residual stenosis on the angiographic edge restenosis of a second-generation drug-eluting stent integrated analysis of quantitative coronary angiography from four postmarketing surveillances of a cobalt-chromium everolimus-eluting stent in japan.".

Event Description

It was reported through a research article identifying that xience v/promus, xience prime, xience prime sv and xience expedition sv maybe related to the following: stenosis, restenosis, thrombosis, occlusion, rehospitalization and revascularization some of which are related to stent bending of less than or equal to 45 degrees and/or unsuccessful implantation (mismatch between the native artery and the stent resulting in poor wall apposition).Specific patient information is documented as unknown.Details are listed in the article, titled "impact of residual stenosis on the angiographic edge restenosis of a second-generation drug-eluting stent integrated analysis of quantitative coronary angiography from four postmarketing surveillances of a cobalt-chromium everolimus-eluting stent in japan.".

Manufacturer Narrative

This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.

• 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
• MDR Report Key: 9929907
• MDR Text Key: 189472155
• Report Number: 2024168-2020-03414
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK RX PRIME
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR