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

Catalog Number ERES25024X

Device Problem Fracture (1260)

Patient Problems Occlusion (1984); Injury (2348)

Event Date 02/27/2014

Event Type  malfunction  

Manufacturer Narrative

Zotarolimus-eluting stent fracture at initial implantation diagnosed with stentboost doi: 10.1177/2050313x16645754 please note that this device (endeavor resolute) is not marketed in the united states; however, it is similar to the united states marketed product (resolute integrity).This event is being reported only as a malfunction because of the similar device requirement in 803 which is limited to malfunctions.If information is provided in the future, a supplemental report will be issued.

Event Description

Patient was admitted to er with unstable angina.Angiography showed 90% stenosis at the cx and obtuse marginal branch of the cx.The obtuse and cx were pre-dilated with a non-medtronic balloons.An endeavor resolute rx drug eluting stent was implanted at 12 atm in the side branch and post-dilated.Subsequently deploying the main branch non-medtronic balloon, a mini crush was performed and another endeavor resolute rx drug eluting stent was implanted at 20 atm into the cx body.The om was rewired and final kissing was performed with non-medtronic nc balloons.Thereafter, localized haziness suggesting thrombosis at first sight appeared in the main-branch stent, both in the proximal part and distal to the om take off.The patient had no symptom and was hemodynamically stable.Stentboost showed stent fracture and disruption.Another endeavor resolute stent was implanted at 14atm to cover the fracture sites.The final result was satisfactory.

• 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: 8598763
• MDR Text Key: 145238361
• Report Number: 9612164-2019-01656
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2015
• Device Catalogue Number: ERES25024X
• Device Lot Number: 0006853833
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2019
• Date Device Manufactured: 08/28/2013
• 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: 58 YR
• Patient Weight: 65