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

Catalog Number ENSP35030X

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Pulmonary Edema (2020)

Event Date 06/09/2014

Event Type  Death  

Event Description

Two endeavor sprint drug eluting stents were implanted in the lad during index procedure.One endeavor sprint drug eluting stent was implanted in the ramus, during a staged procedure approximately 9 days later.The patient expired approximately 36 months post index procedure.Cause of death is reported as acute pulmonary edema.Investigator assessed the event to be not related to the study device.The cec has adjudicated that the death was cardiac.

Manufacturer Narrative

Evaluation results: inherent risk of procedure (death).(b)(4).

• 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: 4643077
• MDR Text Key: 5615482
• Report Number: 9612164-2015-00450
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P090006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2012
• Device Catalogue Number: ENSP35030X
• Device Lot Number: 0002789182
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2015
• Initial Date FDA Received: 03/31/2015
• Date Device Manufactured: 05/13/2010
• 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): Death
• Patient Age: 00056 YR