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

Catalog Number ERES25014X

Device Problems Failure to Advance (2524); Device Dislodged or Dislocated (2923); Physical Resistance/Sticking (4012)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/06/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Four endeavor resolute drug-eluting stents were intended to be used to treat a lesion in the mid lad / diagonal branch with severe calcification, severe tortuosity and 90% lesion stenosis.There was no damage noted to packaging.No issues noted when removing the devices from the hoop.The devices were inspected with no issues noted.Negative prep was performed with no issues noted.The devices passed through a previously deployed stent.Resistance was encountered when advancing.The lesion was pre-dilated.The first stent was placed in the anterior descending branch and it was reported that it was unable to pass through the calcified lesion.The stent was removed, further dilation was applied and another stent was used.The second stent also failed to cross the lesion.The third stent became dislodged after failing to cross the lesion.This stent was expanded in situ.The fourth stent was used to support the implanted stent but it was unable to pass the previous stent.This stent was also deployed.The patient is alive with no injury reported.

Manufacturer Narrative

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

Manufacturer Narrative

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

Manufacturer Narrative

Correction: the second stent (2.5x14mm endeavor resolute) dislodged, not the third stent (2.5x30mmendeavor resolute).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: 7761256
• MDR Text Key: 116872345
• Report Number: 9612164-2018-01973
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/16/2018
• Device Catalogue Number: ERES25014X
• Device Lot Number: 0008056148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2018
• Date Device Manufactured: 05/16/2016
• 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: 78 YR