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

Catalog Number ENSP30024X

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

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Shock (2072); Cardiogenic Shock (2262)

Event Date 01/26/2015

Event Type  Death  

Event Description

The investigator assessed that there was no relationship between the previously reported death and the study device.

Event Description

Patient had emergency treatment for an acute myocardial infarction which they had a one endeavor sprint drug-eluting stent in the lad.The patient was treated with medication but blood pressure continued to decline, carcinogenic shock was diagnosed and the patient expired on the same day.

Manufacturer Narrative

Evaluation codes, results: inherent risk of procedure ¿ (death) evaluation codes, conclusions: 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: 4481834
• MDR Text Key: 5330986
• Report Number: 9612164-2015-00148
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P060033
• 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,Followup
• Report Date: 02/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2017
• Device Catalogue Number: ENSP30024X
• Device Lot Number: A007151370
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2015
• Date Device Manufactured: 05/14/2014
• 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: 00073 YR