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

Catalog Number ERES25024X

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2019

Event Type  malfunction  

Manufacturer Narrative

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

Manufacturer Narrative

Product analysis: the stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the 8th distal stent wraps with struts raised.Please note that this device (endeavor resolute) is not marketed in the united states; however, the device is deemed the same as the united states marketed device (resolute integrity).If information is provided in the future, a supplemental report will be issued.

Event Description

During a procedure an attempt was made to use a resolute integrity rx coronary drug eluting stent and an endeavor resolute rx coronary drug eluting stent to treat a moderately tortuous, moderately calcified lesion exhibiting 85% stenosis located in the ostium of the left main (lm) coronary artery.Both devices were inspected with no issues noted.The lesion was pre-dilated.Negative prep was performed on both devices without issue.Both stents passed through previously implanted stents.Resistance was encountered when advancing the resolute integrity stent, however there was no resistance encountered when advancing the endeavor resolute stent.Excessive force was not used with either device.It was reported that both stents failed to cross the lesion.The procedure was completed using a non-medtronic stent.The patient was reported to be alive with no injury.The devices were returned for evaluation.Stent deformation was visible on both devices.

• 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: 9652286
• MDR Text Key: 188475157
• Report Number: 9612164-2020-00497
• 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: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/23/2020
• Device Catalogue Number: ERES25024X
• Device Lot Number: 0009008643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2018
• 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: 66 YR
• Patient Weight: 43