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

Lot Number UNKNOWN

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Death (1802); Myocardial Infarction (1969); Thrombus (2101); Injury (2348)

Event Date 04/02/2019

Event Type  malfunction  

Manufacturer Narrative

Long-term clinical outcomes of late stent malapposition detected by optical coherence tomography after drug-eluting stent implantation.Doi: 10.1161/jaha.118.011817.If information is provided in the future, a supplemental report will be issued.

Event Description

This study investigated long-term clinical outcomes of optical coherence tomography(oct)-detected late stent malaposition in 351 patients who received drug eluting stents and were examined by both post stent and follow-up oct after drug-eluting stent implantation from january 2009 to december 2011.It was reported that a selection of patients in the study received resolute integrity and endeavor resolute drug eluting stents.Dual antiplatelet therapy (aspirin and clopidogrel) was provided to each patient until the follow-up oct was performed.4 maintenance or discontinuation of dual antiplatelet therapy after the follow-up oct was at the discretion of treating physicians.Reported adverse events on follow up included cardiac death, mi, tvr, stent thrombosis and stent malaposition.

• Brand Name: ENDEAVOR 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: 8678036
• MDR Text Key: 147377305
• Report Number: 9612164-2019-02236
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P060033
• 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: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2019
• 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: 68 YR