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

Lot Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Myocardial Infarction (1969); Thrombus (2101)

Event Date 09/09/2019

Event Type  Injury  

Manufacturer Narrative

Thin, very thin, or ultrathin strut biodegradable or durable polymer-coated drug-eluting stents https://doi.Org/10.1016/j.Jcin.2019.04.054.Patient death(s) were also included in the results of the journal article, however no causal link suggesting that the medtronic device(s) caused or contributed to the death(s) was provided.Information is provided in the future, a supplemental report will be issued.

Event Description

This 3-arm clinical trial enrolled 3,514 all-comer patients who required percutaneous coronary intervention with drug eluting stents (des) implantation between (b)(6) 2012 and (b)(6) 2015.Of the 3,514 patients enrolled in this study, 1,173 patients were implanted with resolute integrity stents.938 patients had at least one complex lesion, 409 patients with at least one bifurcation lesion, 48 patients with at least one chronic total occlusion, 30 with at least one bypass graft, 81 with at least one ostial lesion and 265 with at least one severely calcified lesion.1,131 patients completed 3 year follow-up.The use of dual antiplatelet therapy (dapt) at 3 years was low (6.9%), as was the use of oral anti coagulation therapy plus antiplatelet agents (0.9%), without any between-des difference clinical outcomes included death, myocardial infarction, target vessel revascularization, target lesion revascularization, non¿target vessel revascularization and stent thrombosis.Despite substantial differences in stent backbone and polymer coating, all 3 des showed favorable 3-year safety and efficacy in all comers, without significant between-stent differences.

• Brand Name: RESOLUTE INTEGRITY RX
• Type of Device: STENT, 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 Key: 9184906
• MDR Text Key: 162353584
• Report Number: 9612164-2019-04327
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2019
• Initial Date FDA Received: 10/14/2019
• 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: 64 YR