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

Catalog Number ERES27512X

Device Problems Use of Device Problem (1670); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2018

Event Type  malfunction  

Manufacturer Narrative

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 rx).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

An endeavor resolute drug eluting stent was attempted to be used to treat a moderately tortuous, mildly calcified lesion in the distal lad, exhibiting 85% stenosis.There was no damage noted to the device packaging.There were no issues removing the device from the hoop.The device was inspected with no issues.The lesion was pre-dilated.It is reported that the stent failed to cross and it is indicated that the stent became damaged.The stent was also used past its expiry date.The stent was not implanted.The procedure was completed using another endeavor resolute device.No patient injury is reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 7663028
• MDR Text Key: 113165439
• Report Number: 9612164-2018-01639
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/04/2018
• Device Catalogue Number: ERES27512X
• Device Lot Number: 0008083907
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2018
• Date Device Manufactured: 06/04/2016
• 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: 56 YR