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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEXICO RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING

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MEDTRONIC MEXICO RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING Back to Search Results
Device Problems Fracture; Activation, Positioning or Separation Problem
Event Date 11/26/2019
Event Type  Malfunction  
Manufacturer Narrative

Age: average age. Sex: majority gender. Date of event: date of publication journal article: vascular responses to coronary calcification following implantation of newer-generation drug-eluting stents in humans: impact on healing journal: european heart journal year: 2019 ref: doi:10. 1093/eurheartj/ehz850. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Resolute integrity drug eluting stents were among a number of drug eluting stents used in a study involving autopsy cases which analysed vascular responses to coronary calcification following implantation of newer-generation drug-eluting stents in humans. Out of 134 stents analysed, 29 were resolute integrity stents. Lesions treated included the left main, left circumflex, left anterior artery descending and right coronary artery. Adverse events experienced included stent thrombosis, restenosis, dissection, stent related death, non- stent related cardiac death and non-cardiac death, explant due to heart transplant death and target lesion revascularization. Malfunctions reported included stent fracture and strut malapposition which were assessed through imaging. It was also reported that a (b)(6) year old patient with a medical history of hypertension, diabetes and coronary artery disease had a resolute integrity des implanted. One year post implant the patient died. Low power images of stented sections for this patient demonstrated in-stent restenosis with a large medial tear in a severely calcified artery. Strut malapposition was also observed.

 
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Brand NameRESOLUTE INTEGRITY RX
Type of DeviceSTENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,bc 22570
MX  22570
Manufacturer (Section G)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,bc 22570
MX  22570
Manufacturer Contact
toni o'doherty
parkmore business park west
galway  
091708734
MDR Report Key9584879
Report Number9612164-2020-00207
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/24/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/14/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received01/29/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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