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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING

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MEDTRONIC IRELAND RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING Back to Search Results
Device Problems Fracture; Improper or Incorrect Procedure or Method
Event Date 04/24/2019
Event Type  Malfunction  
Manufacturer Narrative

Journal article: comparison of drug eluting versus bare metal stents for pulmonary vein stenosis in childhood journal: catheterization and cardiovascular interventions year: 2019 ref: doi: 10. 1002/ccd. 28328 a2: average age a3: majority gender b3: date of publication death was reported as a clinical outcome of this study, however there is no information to suggest the device has caused or contributed to a death. Medication: antiplatelet therapy, aspirin. If information is provided in the future, a supplemental report will be issued.

 
Event Description

A retrospective review of all stent implants for pulmonary vein stenosis (pvs) between august 1993 and november 2017 was conducted in this study. Resolute integrity rx coronary des was among the 111 drug eluting stents implanted in 41 patients to treat 105 lesions. Prior to implantation of stents, resistant lesions were prepared to abolish any residual waist. All patients were started on antiplatelet therapy within 24 hr of stent implant unless a contraindication existed. Post implantation three major complications were reported; bleeding in the endotracheal tube related to mechanical trauma during transfer, thrombus in the distal vein post stent implantation treated with aspiration thrombectomy and pulmonary haemorrhage noted a few days after catheterization. Initial and long term follow-up catheterizations included stent re-dilations, distal lesions treated with angioplasty and placement of new stents, lesions with repeat stenting with des for restenosis and complete occlusion. Multiple stents were intentionally fractured on follow-up catheterization to achieve diameter >6 mm. 10 patient deaths were reported. Medtronic judkins right guide catheters were used during the procedures. No alleged product issue or adverse events reported for these devices.

 
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Brand NameRESOLUTE INTEGRITY RX
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 Key9206542
Report Number9612164-2019-04413
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,LITERATUR
Reporter Occupation
Type of Report Initial
Report Date 10/18/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/18/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received09/18/2019
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: 10/18/2019 Patient Sequence Number: 1
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