Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND INTEGRITY OTW; STENT, CORONARY
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC IRELAND INTEGRITY OTW; STENT, CORONARY Back to Search Results
Catalog Number INT30022W
Medical Device Problem Code Material Deformation (2976)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/05/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Physician was attempting to treat an in-stent restenosis lesion in the lad using integrity bare metal stent (bms).The device was prepped prior to use.The device was inspected prior to use.The device did pass through a previously deployed stent.Resistance was encountered while advancing the device.It was reported that during use the struts were damaged.The device was trying to pass through a previously deployed non medtronic stent which had in-stent restenosis when the damage to the stent struts occurred.Patient status post procedure is fine.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INTEGRITY OTW
Common Device Name
STENT, CORONARY
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
MDR Report Key7166983
Report Number9612164-2018-00025
Device Sequence Number13816777
Product Code MAF
UDI-Device Identifier00613994602374
UDI-Public00613994602374
Combination Product (Y/N)N
Initial Reporter StateIA
Initial Reporter CountryUS
PMA/510(K) Number
P030009
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date06/23/2018
Device Catalogue NumberINT30022W
Device Lot Number0008110972
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/08/2017
Initial Report FDA Received Date01/05/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-