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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/18/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a full term new born received an endeavor resolute stent deployed in a straight short conical duct.On the second post-natal day the stent migrated, possibly due to inadequate ductal constriction, persisting prostaglandin effect, and straight short ductal morphology.It was successfully retrieved using a larger balloon and redeployed in the duct again.Intravenous indomethacin was administered to prevent further stent migration.The patient was discharged after 3 days.

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: 7818507
• MDR Text Key: 118291810
• Report Number: 9612164-2018-02185
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2019
• 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: 2 DA
• Patient Weight: 2