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U.S. Department of Health and Human Services

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

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MEDTRONIC IRELAND RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING Back to Search Results
Device Problem Activation, Positioning or SeparationProblem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess performance of the resolute integrity rx drug-eluting coronary stent system. Survey results from an interventional cardiologist in practice 10 years. In the past 12 months the physician has used the resolute integrity rx drug-eluting stent 80 times. 15 of the smallest (2. 25 x 8 mm), 40 of the intermediate (2. 25 x 12 mm to 4. 00 x 24 mm) and 25 of the largest (4. 00 x 30 mm) sizes were used. It was noted that in the last 12 months the medtronic resolute integrity rx drug-eluting coronary stent system was used coronary stenting procedures including those with multivessel disease, acute coronary syndrome (acs), bifurcation lesions, in-stent restenosis (isr), and total occlusions (to or cto). The following complications adverse events/effects were encountered in the using the product over the last 12 months: four death events, all related to a pre-existing condition or comorbidity. Five emergency surgery or coronary bypass events, all related to a pre-existing condition or comorbidity. Two cardiac artery perforation events, both related to the procedure but not directly to the device itself. Two shock/pulmonary edema events, both related to a pre-existing condition or comorbidity. Two cardiac artery spasm events, both related to the procedure but not directly to the device itself. The following malfunctions were also encountered in the using the product over the last 12 months: two deployment difficulties events with no impact on procedure. Two inflation difficulties events with no clinical/patient impact. Three insertion difficulties events with no impact on procedure. Four positioning difficulties events with no clinical/patient impact. It was reported that the device did not perform as expected in terms of reaching the target lesion in 5 cases due to the wrong size being chosen. It was reported that the device did not perform as expected in terms of dilation of the target lesion in 3 cases due to the stenosis being fixed. It was reported that the device did not perform as expected in terms of the ability to achieve thrombolysis in myocardial infarction (timi) flow 3 in 3 cases due to the lesion being fixed/chronic.
 
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Brand NameRESOLUTE INTEGRITY RX
Type of DeviceSTENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
 
091708734
MDR Report Key10502299
MDR Text Key205942241
Report Number9612164-2020-03388
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P110013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/08/2020
Is this an Adverse Event Report? No
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 Received08/28/2020
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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