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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 Problems Activation, Positioning or SeparationProblem (2906); Device Dislodged or Dislocated (2923)
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 a cardiothoracic surgeon in practice 17 years. In the past 12 months, the physician has used the resolute integrity stent 100 times. 20 of the smallest (2. 25 x 8 mm), 70 intermediate (2. 25 x 12 mm to 4. 00 x 34 mm) and 10 of the largest (4. 00 x 38 mm) sizes of these stents were used. The following device complaints were encountered in procedure when using the resolute integrity product over the last 12 months: two cases of stent dislodged prior to deployment, both of which had no clinical/patient impact. Twenty cases of positioning difficulties, all of which had no clinical/patient impact. Ten cases of incomplete stent expansion, all of which had no clinical/patient impact. Five cases of the resolute integrity not performing as expected in terms of reaching the target lesion were reported stating that the pre-dilated stenosis could not be crossed with the stent. In addition, ten cases of the resolute integrity not performing as expected in terms of dilation of the target lesion were reported stating that after implantation of the stent, partial recoiling had occurred and, therefore, a good result was not obtained from observing ivus.
 
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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 Key10238432
MDR Text Key197765547
Report Number9612164-2020-02452
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 07/15/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/07/2020
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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