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

Catalog Number ERES35018X

Device Problem Material Distortion (2977)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2015

Event Type  malfunction  

Event Description

It is reported that a endeavor resolute drug eluting stent was intended to treat a severely calcified lesion in the lad.The lesion had 85% stenosis and minor tortuosity.The patient also had a totally occluded rca.No issues were noted with the device packaging.The device was inspected prior to use with no issues noted.The lesion was pre-dilated twice for 5 seconds, at 8 atm.20% stenosis remained after pre-dilation.The device was successfully implanted at the target lesion, but it is reported that the "stent was shortening from the left coronary into lad , and could not cover the lesion." no stent deformation or migration was noted.The device remains in the patient.The physician deployed another endeavor resolute rx of same size to complete the surgery.A non-medtronic device was used to treat the cto in the rca.The physician believes the cause of the event may be due to a product defect.No patient complications are reported.Please note that this device (endeavor resolute rx) is not marketed in the united states; however, it is similar to the united states marketed device (resolute integrity).This event is being reported only as a malfunction because of the similar device requirement in 803 which is limited to malfunctions.

Manufacturer Narrative

Evaluation results: (based of details received and non return of cine images for review the root cause for this event cannot be determined).No results available since no evaluation performed (device or procedural images not returned for review) evaluation conclusions: unable to confirm complaint (procedural images not returned for review).(based of details received and non return of cine images for review the root cause for this event cannot be determined).(b)(4).

• 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: 4864792
• MDR Text Key: 5809390
• Report Number: 9612164-2015-01078
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2016
• Device Catalogue Number: ERES35018X
• Device Lot Number: 0007367004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2015
• Date Device Manufactured: 11/13/2014
• 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: 00078 YR