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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number UNK RX PROMUS
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/promus 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. You are receiving this mdr report from abbott vascular because boston scientific corporation distributed promus as its own brand labeling of abbott vasculars drug eluting stent in the us. The xience v, xience prime, xience prime sv and xience xpedition sv devices are being filed under separate medwatch report numbers. Attachment 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 (b)(6). ".
 
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 attached 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 (b)(6). ".
 
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Brand NamePROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Type of DeviceDRUG 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 Key9929844
MDR Text Key189471462
Report Number2024168-2020-03412
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeJA
PMA/PMN Number
P070015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
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 Received04/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK RX PROMUS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/06/2020 Patient Sequence Number: 1
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