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

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/18/2019

Event Type  malfunction  

Manufacturer Narrative

Journal article: impact of late stent malapposition after drug-eluting stent implantation on long-term clinical outcomes.Journal: elsevier year: 2019 ref: doi: https://doi.Org/10.1016/j.Atheroscl.Age or date of birth: average age.Sex: majority gender.Date of event: date of publication.The endeavor resolute rx coronary drug eluting stent is similar to the resolute integrity rx coronary drug eluting stent which is marketed in the us.If information is provided in the future, a supplemental report will be issued.

Event Description

Long-term clinical outcomes of late stent malapposition (lsm) detected by optical coherence tomography (oct) were evaluated in a total of 428 patients who were selected from previous randomized oct studies.These patients were assigned to one of two groups based on the presence (n = 136) or absence (n = 292) of lsm on follow-up oct images.123 endeavor resolute drug eluting stents were among a number of des implanted.Post implantation 32 endeavour resolute des devices were found to have late stent malapposition.The left anterior descending artery was the only lesional characteristic reported.Follow-up oct was performed post-intervention.Clinical events included target vessel-related myocardial infarction, target vessel r evascularization, target lesion-related myocardial infarction, target lesion revascularization.It was noted that the presence of oct-detected lsm was not associated with adverse clinical events.

• Brand Name: ENDEAVOR RESOLUTE 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: 8978889
• MDR Text Key: 157108894
• Report Number: 9612164-2019-03814
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2019
• 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: 62 YR