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); Thrombosis (2100); Cardiogenic Shock (2262); Stenosis (2263); Injury (2348)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Journal article: unprotected left main percutaneous coronary intervention: prognostic value of syntax score ii journal: tunisie medicale year: 2019 ref: (b)(4).(b)(4).Average age, majority gender, date of publication medication: dual antiplatelet therapy there is no information to suggest the device caused or contributed to the death events.Deaths are common occurrences in clinical studies, however the cause(s) of death are often not characterized or clearly associated with a particular product.Therefore, deaths will not be considered reportable unless clearly stated as being associated with a medtronic device.If information is provided in the future, a supplemental report will be issued.

Event Description

From january 2012 to december 2017, 150 consecutive patients with unprotected lm-cad treated by pci were prospectively analyzed in this, ¿all-comers¿, monocentric registry.Lesion characteristics included bifurcation, calcification, total occlusion and thrombus.Zotarolimus eluting stents were implanted in 64 patients.In hospital adverse outcomes consisted of four deaths (3 for cardiogenic shocks and one for major femoral access site bleeding) and one non-fatal mi due to a definite subacute stent thrombosis.Adverse events from follow-up at 13.4 months included all-cause death in 16 patients, among them 12 were adjudicated as cardiac deaths, mi occurred in 5 cases and tlr in 14 cases.In-stent restenosis was observed in 13 patients and a total of 4 patients experienced definite or probable stent thrombosis.Tvr was reported in 19 cases.Cerebrovascular accident complicated follow-up in 2 patients.

• 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: 9389978
• MDR Text Key: 168586711
• Report Number: 9612164-2019-04938
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: TS
• 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: 11/28/2019

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2019
• Initial Date FDA Received: 11/28/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 65 YR