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

Device Problems Structural Problem (2506); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Occlusion (1984)

Event Date 06/01/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient had two endeavor stents implanted during a procedure.Approximately 1-month post procedure the cardiologist confirmed one of the stents had closed up.Possible bypass is planned in the near future.No further patient complications have been reported as a result of this event.Asking how long her coronary stents were supposed to last.I told her they stay in place for the duration of her lifetime.She then stated that her cardiologist told her one of them "closed up".Caller had a cath done "about a month ago".I let her know that the blockage is not necessarily due to the presence of the stent and patency can vary from patient to patient based on anatomy, lifestyle and other factors such as her clotting anomaly.Caller understood and wanted to confirm there were no recalls she may have missed.

Manufacturer Narrative

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

• Brand Name: ENDEAVOR SPRINT 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: 7757531
• MDR Text Key: 116255466
• Report Number: 9612164-2018-01950
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• 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 Outcome(s): Other