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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND INTEGRITY RX; STENT, CORONARY
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MEDTRONIC IRELAND INTEGRITY RX; STENT, CORONARY Back to Search Results
Catalog Number INT40022X
Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Event Date 07/03/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that an integrity bare metal stent was implanted in a patient approximately16 days post expiry.No damage was noted to packaging.No issues were noted when removing the device from the hoop.The device was not inspected.Negative prep was not performed.No medical or surgical intervention was used.The patient's current status is alive.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
INTEGRITY RX
Type of Device
STENT, CORONARY
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 Key7731459
MDR Text Key115594019
Report Number9612164-2018-01895
Device Sequence Number0
Product Code MAF
Reporter Country CodeSP
PMA/PMN Number
P030009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2018
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/17/2018
Device Catalogue NumberINT40022X
Device Lot Number0008398528
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/08/2018
Date Device Manufactured06/18/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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