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

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.

Manufacturer Narrative

Additional information: annex d code procedural images in the article provided the basis of the analysis.The images confirm the reported hinge motion of the stent distal site.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE INTEGRITY RX
• Type of Device: CORONARY 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 Key: 13649986
• MDR Text Key: 286430114
• Report Number: 9612164-2022-00842
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• 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 Received: 03/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male