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U.S. Department of Health and Human Services

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

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MEDTRONIC IRELAND ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING Back to Search Results
Device Problems Burst Container or Vessel (1074); Activation, Positioning or SeparationProblem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The physician in this case consented to participate in the survey but did not consent to be contacted regarding the information provided and wished to remain anonymous, therefore information for facility and city cannot be provided. Please note that this device (endeavor resolute) is not marketed in the united states; however, it is similar to the united states marketed product (resolute integrity). This event is being reported only as a malfunction because of the similar device requirement in 803 which is limited to malfunctions. 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 endeavor resolute drug-eluting coronary stent system. Survey results from an interventional cardiologist in practice 12 years. In the past 12 months the physician has used the endeavor resolute rx drug-eluting stent 150 times. 35 of the smallest (2. 25 x 8 mm), 75 of the intermediate (2. 25 x 12 mm to 4. 00 x 24 mm) and 40 of the largest (4. 00 x 30 mm) sizes were used. It was also noted that inthe last 12 months the endeavor resolute drug-eluting coronary stent system was used in non-coronary procedures including 60 peripheral artery disease treatments. The following complications adverse events/effects were encountered in the using the product over the last 12 months: two balloon rupture events, related to a pre-existing condition or comorbidity one rash event, related to a pre-existing condition or comorbidity it was reported that the device did not perform as expected in terms of reaching the target lesion in 5 cases due to it not being possible to intervene the lesion. 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 lesion being too calcified. 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 2 cases due to pronounced thrombosis.
 
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Brand NameENDEAVOR RESOLUTE 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 Key10501388
MDR Text Key207738522
Report Number9612164-2020-03382
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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