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U.S. Department of Health and Human Services

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

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MEDTRONIC IRELAND RESOLUTE INTEGRITY RX CORONARY DRUG-ELUTING STENT Back to Search Results
Device Problem Material Deformation (2976)
Patient Problems Angina (1710); Myocardial Infarction (1969); Obstruction/Occlusion (2422)
Event Date 07/19/2021
Event Type  Injury  
Manufacturer Narrative
Journal article: a case of a coronary covered stent for repeated restenosis at the anastomosis site between saphenous vein graft and graft prosthesis authors: masaomi gohbara, teruyasu sugano, toshiyuki ishikawa, kouichi tamura, kazuo kimura journal: journal of cardiology cases year: 2022 reference: doi. Org/10. 1016/j. Jccase. 2021. 07. 007. If information is provided in the future, a supplemental report will be issued.
 
Event Description
A case study was submitted for review titled: a case of a coronary covered stent for repeated restenosis at the anastomosis site between saphenous vein graft and graft prosthesis. Two months after surgery to treat an acute aortic dissection and mechanical aortic valve implantation, a patient was diagnosed with non-st-segment elevation myocardial infarction (nstemi). Coronary angiography (cag) revealed a 99% stenosis of the anastomosis site between the saphenous vein graft (svg) and the j graft. A resolute integrity drug eluting stent (des) was implanted in the anastomosis site between the svg and j graft. Repeated restenosis at the anastomosis site occurred requiring repeated percutaneous coronary interventions (pcis). Six months after the this pci, a 2nd pci was performed with plain old balloon angioplasty (poba) using a 3. 25 mm non-medtronic non-compliant (nc) balloon and a 3. 5 mm non-mdt drug coated balloon (dcb). There was a hinge motion of the stent distal site. Eleven months after the 2nd pci, a 3rd pci was performed with poba using a 3. 5 mm nc balloon and a 3. 5 mm dcb. Eight months after the 3rd pci, a 4th pci was performed with poba using a 3. 75 mm nc balloon and a 3. 5 mm dcb. Eleven months after the 4th pci, a 5th pci was performed with excimer laser catheter ablation, followed by poba using a 3. 5 mm scoring balloon and a 3. 5 mm dcb. One year after the 5th pci, a 6th pci was performed with directional coronary atherectomy (off-label use) to cut the in-stent neointimal proliferation and a 3. 0 mm dcb. The patient received triple therapy composed of dual antiplatelet therapy and a vitamin k antagonist (vka) within 1 month after each pci. Despite these medical therapies and repeated pcis, the patient was admitted again due to angina pectoris with exertion and inferior myocardial ischemia by stress myocardial perfusion imaging. Cag revealed total occlusion of the stent from the anastomosis site and good collateral flow from septal branches of his left ascending artery to his right coronary artery. Therefore; one year after the 6th pci, a 7th pci was performed. Coronary orbital atherectomy, pre-dilatation with a 3. 5 mm cutting balloon was performed and a non-mdt des was implanted in the distal lesion overlapping with the previous stent. Subsequently, a non-mdt covered stent was implanted to cover the anastomosis site with a 4. 0 mm balloon for post-dilatation, resulting in three stents partially overlapping. The hinge motion of the stent distal site was improved. Six months after the 7th pci, follow-up cag revealed that the covered stent remained clearly open, with restenosis of the ballooning site of svg that was distal to those stents. Therefore, a non-mdt des was implanted during an 8th pci by optical frequency domain imaging (ofdi) guided pci. Finally, seven months after the 8th pci, follow-up cag revealed that the covered stent and previous stents all remained clearly open.
 
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Brand NameRESOLUTE INTEGRITY RX
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
EI
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
EI
Manufacturer Contact
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key13649986
MDR Text Key286430114
Report Number9612164-2022-00842
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P110013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/13/2022
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: 03/02/2022 Patient Sequence Number: 1
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