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 Myocardial Infarction (1969); Blood Loss (2597); Thrombosis/Thrombus (4440)

Event Date 07/04/2020

Event Type  Injury  

Manufacturer Narrative

Journal article: new-generation drug-eluting coronary stents in octogenarians: patient-level pooled analysis from the twente i-iv trials authors: eline h.Ploumen, rosaly a.Buiten, carine j.M.Doggen, martin g.Stoel, k.Gert van houwelingen, carl e.Schotborgh, gillian a.J.Jessurun, ariel roguin, peter w.Danse, edouard benit, adel aminian, gerard c.M.Linssen, frits h.A.F.De man, marc hartmann, diedrik g.Buiten, marlies m.Kok, paolo zocca and clemens von birgelen journal: american heart journal year: 2020 reference: doi.Org/10.1016/j.Ahj.2020.07.003 there is no established or suspected causal relationship between the device and 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

A journal article was submitted.The aim of the study was to assess the 1-year clinical outcome of octogenarians treated with new-generation des versus younger patients.Patient level data of 9,204 participants from four randomized trials (twente, dutch peers, bio-resort and bionyx (twente i-iv) was pooled.A total of 671 patients were octogenarians.Resolute integrity and resolute onyx were among the new-generation des devices used.Clinical outcomes at the 1 year follow-up included any death, cardiac death, any mi, including target vessel mi and periprocedural mi, any revascularization, including target vessel revascularization and target lesion revascularization, target vessel failure, definite or probable stent thrombosis and any bleeding which included major bleeding.

• Brand Name: RESOLUTE INTEGRITY RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 10776737
• MDR Text Key: 214799764
• Report Number: 9612164-2020-04200
• 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: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• 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
• Date Manufacturer Received: 10/15/2020
• 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: 72 YR