• 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 RESOLUTE INTEGRITY OTW STENT, CORONARY, DRUG-ELUTING

  • 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 RESOLUTE INTEGRITY OTW STENT, CORONARY, DRUG-ELUTING Back to Search Results
Catalog Number RSINT30030W
Device Problems Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem
Event Date 11/20/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

Patient came in as with stemi, with stent thrombosis in previous non medtronic stent. The physician treated a non-tortuous and moderately calcified lesion in the mid rca using one resolute integrity drug eluting stent. Vessel diameter was 3. 5mm and lesion length was 26mm. There was no abnormality reported in relation to anatomy. No damage was noted on the device packaging and no issues were noted removing the device from the hoop. The device was inspected and negative prep was performed with no issues noted. The lesion was not pre-dilated. The device passed through the previously deployed stent which is non-medtronic. No resistance was encountered when advancing the device and excessive force was not used during delivery. Physician ballooned and placed the resolute integrity drug eluting stent in the rca. The stent was deployed to 14 atm. Twenty minutes after arriving in ccu, patient developed st elevation. The call team was called back in and it was noted that the stent had thrombosis. The lesion was ballooned and stented proximal and distal to the stent. Both the previously deployed stent and resolute integrity stent were noted to be undersized by the physician. When the patient returned to the lab, the physician went in with a larger sized stent and balloon. There was no mislabelled issue. The patient is alive and doing well.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRESOLUTE INTEGRITY OTW
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 Key7112450
Report Number9612164-2017-01912
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 12/13/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/13/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberRSINT30030W
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 Received11/20/2017
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

Patient TREATMENT DATA
Date Received: 12/13/2017 Patient Sequence Number: 1
-
-