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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 Burst Container or Vessel (1074); Activation, Positioning or SeparationProblem (2906); Detachment of Device or Device Component (2907)
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 7 years. In the past 12 months, the physician has used the resolute integrity stent 300 times. 40 of the smallest (2. 25 x 8 mm), 250 intermediate (2. 25 x 12 mm to 4. 00 x 34 mm) and 10 of the largest sizes (4. 00 x 38 mm) of these stents were used. It was noted that the 5 devices were used in other non-coronary procedures to treat other arteries. The following complications adverse events/effects were encountered in the using the resolute integrity product over the last 12 months: four incomplete stent apposition events, all related to the procedure but not directly to the device itself. The following device complaints were encountered when using the resolute integrity product over the last 12 months: two events in which a burst balloon occurred. Both events reportedly had no clinical/patient impact. Two events in which detachment of component(s) (in vivo) occurred. Both events reportedly also had no clinical/patient impact. It was reported that the device did not perform as expected in terms of reaching the target lesion in 10 events because the lesion was unreachable due to calcification and strong kinking. It was also reported that in 5 events the device did not perform as expected in terms of dilation of the target lesion. It was stated that the lesion could not be sufficiently expanded due to massive calcification.
 
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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 Key10249427
MDR Text Key198312925
Report Number9612164-2020-02495
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 07/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/09/2020
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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