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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 Problem Activation, Positioning or Separation Problem (2906)
Patient Problems Intimal Dissection (1333); Death (1802); Stenosis (2263)
Event Date 11/26/2019
Event Type  Death  
Manufacturer Narrative
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, target lesion revascularization. Malfunctions reported included stent fracture and strut malapposition which were assessed through imaging. It was also reported that a (b)(6) 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.
 
Manufacturer Narrative
Additional information: medtronic devices were not related to stent related deaths. There were no cases with stent related deaths after medtronic devices in this study population. There is no stent thrombus and dissection in medtronic devices. Target lesion revascularisation cannot be evaluated in the autopsy study since this is not end point in the autopsy study and only this information can be collected by clinical phases. In-stent restenosis was found in 7 lesions with medtronic devices but there are no significant differences between devices. The presence of calcification in underlying eccentric plaque affected medial tear rather than the type of stent because the stent could be expanded only toward non-calcified area. If information is provided in the future, a supplemental report will be issued.
 
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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 Key9584938
MDR Text Key174839832
Report Number9612164-2020-00210
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P110013
Number of Events Reported1
Summary Report (Y/N)N
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
1 Patient was Involved in the Event
Date FDA Received01/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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

Patient Treatment Data
Date Received: 01/14/2020 Patient Sequence Number: 1
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