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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
Catalog Number ERES35030X
Device Problems Fracture (1260); Inflation Problem (1310)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/12/2020
Event Type  malfunction  
Manufacturer Narrative
The endeavor resolute rx coronary drug eluting stent is similar to the resolute integrity rx coronary drug eluting stent which is marketed in the us.If information is provided in the future, a supplemental report will be issued.
 
Event Description
An endeavor resolute rx coronary drug-eluting stent was intended to be used during a procedure to treat a non-tortuous, non-calcified lesion exhibiting 80% stenosis in the left circumflex (lcx) artery.There was no damage noted to the device packaging.There were no issues noted when removing the device from the hoop.The device was inspected prior to use with no issues noted.Negative prep/purging was performed with no issues noted.The device did not pass through a previously-deployed stent.Resistance was not encountered when advancing the device and excessive force was not used.The luer of the endeavor resolute was connected directly to a non-medtronic inflation device with no issues noted.No crack was noted prior to attaching the luer of the endeavor resolute to the non-medtronic inflation device.It was reported that the luer of the device cracked while attempting to inflate the device.It was also reported that during inflation there was insufficient balloon inflation due to the air leak from the cracked luer.The device was eventually implanted after initial difficulties with insufficient balloon inflation due to cracked luer.The patient was reported to be alive with no injury.
 
Manufacturer Narrative
Additional information: the lesion was not pre-dilated.It was stated that it was impossible to define what the inflation pressure (atm) was when the inflation difficulties were noted due to the constant leak of air from the crack in the luer.It was also stated that it was impossible to define the inflation pressure (atm) applied to the balloon which allowed the stent to be deployed due to the constant leak of air from the crack in the luer.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
ENDEAVOR RESOLUTE RX
Type of Device
STENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
MDR Report Key10047583
MDR Text Key190660729
Report Number9612164-2020-01861
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
PMA/PMN Number
P110013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/07/2021
Device Catalogue NumberERES35030X
Device Lot Number0009959102
Was Device Available for Evaluation? No
Date Manufacturer Received07/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age64 YR
Patient Weight86
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