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

Device Problem Activation, Positioning or SeparationProblem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

Title: clinical implications of poststent optical coherence tomographic findings severe malposition and cardiac events authors: byung gyu kim, md, mateusz kachel, jung-sun kim, giulio guagliumi et al. Journal: jacc: cardiovascular imaging issue: 1 ref: https://doi. Org/10. 1016/j. Jcmg. 2021. 03. 008. Average age, majority gender, date of publication patient deaths were also included in the results of the journal article, however no causal link suggesting that the medtronic devices used in the patient cohort may have caused or contributed to the death(s) was provided. If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted for review titled: clinical implications of poststent optical coherence tomographic findings: severe malposition and cardiac events. The aim of the study was to evaluate the impact of poststent optical coherence tomography (oct) findings including severe malposition on long-term clinical outcomes. A total of 1,290 patients with 1,348 lesions who underwent oct immediately post stenting were eligible for this study and were enrol led. Lesions treated included the left main, left anterior descending artery, left circumflex artery, right coronary artery and ramus intermedius. Lesions had a mean stenosis of 66%. Patients received drug-eluting stents (des) including sirolimus-eluting stents, paclitaxel-eluting stents, zotarolimus eluting stents, everolimus eluting stents or biolimus a9-eluting stents. Medtronic endeavour rx stents and resolute integrity stents were the zotarolimus eluting stents used during this study. Each des was implanted according to current standard techniques and pre-dilation, post-stent dilation, application of mechanical support or concomitant medication, were performed at the discretion of the operator. Post-stent oct findings included stent edge dissection, stent malposition, malposed struts, tissue protrusion/prolapse, thrombus and stent under expansion. Follow up oct was performed at 3, 6, or 12 months after the initial angioplasty. Cardiac deaths, definite, probable and possible stent thromboses, stent occlusion, target vessel-related mi and target lesion revascularization (tlr).

• 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: 14141491
• MDR Text Key: 289515888
• Report Number: 9612164-2022-01507
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/19/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2022
• 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