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

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

Patient Problems Myocardial Infarction (1969); Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559)

Event Date 02/10/2020

Event Type  Injury  

Manufacturer Narrative

Journal article: treating very long coronary artery lesions in the contemporary drug eluting-stent era: single long 48 mm stent versus two overlapping stents showed comparable clinical outcomes authors: hui wen sim, elizabeth h.Thong, poay huan loh, chi-hang lee, mark y.Chan, adrian f.Low, edgar l.Tay, koo hui chan, huay cheem tan, joshua p.Loh journal: cardiovascular revascularization medicine year:2020 reference: doi.Org/10.1016/j.Carrev.2020.02.005 patient deaths were also included in the results of the journal article, however no causal link suggesting that the medtronic device used in the patient cohort may have caused or contributed to the deaths was provided.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article titled - treating very long coronary artery lesions in the contemporary drug-eluting-stent era: single long 48 mm stent versus two overlapping stents showed comparable clinical outcomes - was submitted for review.This study aimed to compare the two-year clinical outcomes between 48 mm single long contemporary drug eluting stents (des) versus two overlapping contemporary des in the treatment of very-long coronary artery disease (cad).The primary endpoint was target lesion failure (tlf) at two years, defined as a composite of cardiac mortality, target vessel myocardial infarction (mi), and target lesion revascularization (tlr).Additional endpoints included major adverse cardiovascular events (mace); defined as a composite of all-cause mortality, mi, or ischemia driven tlr, definite and probable stent thrombosis (st), and the individual components of tlf and mace.Deaths not attributable to another cause were considered cardiac deaths.A total of 117 patients were treated with single long 48 mm single long des (sl-des) versus 101 patients treated with two overlapping contemporary des (ol-des).All the patients in sl-des group received a non-medtronic (mdt) stent, while patients assigned to the ol-des group received either medtronic resolute integrity des or other non-mdt des.Events of tlf, mace and their individual components was seen in both the sl-des and ol-des study groups at two years.There were two cases of sudden cardiac death that categorized as probable st (one in each treatment group) without angiographic confirmation.

• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 11973410
• MDR Text Key: 255331252
• Report Number: 9612164-2021-02248
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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
• Report Date: 06/10/2021

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: 05/17/2021
• Initial Date FDA Received: 06/10/2021
• 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: 60 YR