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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 coronary drug-eluting stent. Survey results from an interventional cardiologist in practice 30 years. In the past 12 months, the physician has used the resolute integrity stent 500 times. 40 of the smallest (2. 25 x 8 mm), 380 intermediate (2. 25 x 12 mm to 4. 00 x 34 mm) and 80 of the largest sizes (4. 00 x 38 mm) of these stents were used. It was stated that the incomplete stent apposition events were associated specifically with the use of the device because there was a mismatch between the vessels and the stents. This was detected due to the presence of a cto. Post dilation was then performed. It was reported that the device did not perform as expected in terms of reaching the target lesion in five events due to stent protrusion not being possible. It was also reported that the device did not perform as expected in terms of dilation of the target lesion in five events due to a s tent-vessel mismatch.
 
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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 Key10246079
MDR Text Key198315936
Report Number9612164-2020-02485
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/08/2020
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 Received06/22/2020
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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