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

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

Patient Problems Stroke/CVA (1770); Myocardial Infarction (1969); Thrombus (2101); Injury (2348); Blood Loss (2597)

Event Date 07/03/2019

Event Type  Injury  

Manufacturer Narrative

Resolute zotarolimus-eluting stent in st-elevation myocardial infarction (resolute-ste<(><<)>i): a prespecified prospective register from the dapt-stemi trial doi: 10.1002/ccd.28376.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that resolute integrity rx drug eluting stents were used as part of a study evaluating the safety and efficacy outcomes after primary pci in patients enrolled in the dapt-stemi trial.998 patients received the resolute integrity stents.Adverse events reported at 30 days and 6 month follow up included all-cause death (8 patients died, seven of which were cardiac deaths), mi, revascularization, stroke and timi major bleeding was respectively 8 (0.8%), 9 (0.8%), 34 (3.4%), 2 (0.2%), and 4 (0.4%).The rate of target lesion revascularizations involving the culprit lesion was 1.1%.Target lesion failure was 1.5%.The rate of definite st was 0.5%.The rate of both definite or probable st was 0.7%.

• 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: 8939671
• MDR Text Key: 156574508
• Report Number: 9612164-2019-03616
• 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: Other
• Type of Report: Initial
• Report Date: 08/28/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/19/2019
• Initial Date FDA Received: 08/28/2019
• 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 Age: 60 YR