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 RESOLUTE INTEGRITY RX; 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 RX; STENT, CORONARY, DRUG-ELUTING Back to Search Results
Catalog Number RSINT22526UX
Medical Device Problem Code Device Expiration Issue (1216)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/29/2017
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that a resolute integrity rx drug eluting stent was implanted approximately 7 months post its expiry date.No patient injury or medical/surgical intervention was required.It was reported that the product was on consignment at the account.The account has a signed consignment agreement and are responsible for controlling short dated/expired product.Patient reported as ok.
 
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
RESOLUTE INTEGRITY RX
Common Device Name
STENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
MDR Report Key6553414
Report Number9612164-2017-00569
Device Sequence Number13592545
Product Code NIQ
UDI-Device Identifier00643169037441
UDI-Public00643169037441
Combination Product (Y/N)N
Initial Reporter CountryDR
PMA/510(K) Number
P110013
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 04/10/2017
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 Date08/31/2016
Device Catalogue NumberRSINT22526UX
Device Lot Number0007926999
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/10/2017
Supplement Date Received by Manufacturer04/10/2017
Initial Report FDA Received Date05/09/2017
Supplement Report FDA Received Date10/03/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-