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

Catalog Number ENSP25014X

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

Patient Problems Death (1802); Myocardial Infarction (1969); Renal Failure (2041)

Event Date 09/26/2013

Event Type  Injury  

Event Description

It is reported that patient suffered an mi approximately 22 months post index procedure.Investigator assessed that the reported event was unlikely to be related to the study device.

Manufacturer Narrative

Evaluation results: inherent risk of procedure ¿ (myocardial infarction).Evaluation conclusions: inherent risk of procedure ¿ (myocardial infarction).(b)(4).

Event Description

During index procedure, the patient had one endeavor sprint drug-eluting stent implanted to the ramus.Approximately 23 months post index procedure, patient death occurred.Cause of death was renal failure.The clinical events committee adjudicated that patient death was cardiac death.Investigator indicated that the death was not related to the study device.Cec adjudicated that the patient suffered an mi on the date of death.The mi event was not assessed for relatedness with device.

Manufacturer Narrative

Evaluation, results, conclusions: inherent risk of procedure ¿ (death, myocardial infarction).(b)(4).

Manufacturer Narrative

Evaluation conclusions: inherent risk of procedure ¿ (stent thrombosis).(b)(4).

Event Description

Death is reported as non cardiac due to renal insufficiency.It is reported that the patient experienced stent thrombosis on date of death.

• 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: 3786229
• MDR Text Key: 4474466
• Report Number: 9612164-2014-00491
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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,Followup
• Report Date: 09/10/2014

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: 01/06/2013
• Device Catalogue Number: ENSP25014X
• Device Lot Number: 0005380808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/10/2014
• Initial Date FDA Received: 05/02/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/15/2014; 09/15/2014
• Date Device Manufactured: 01/07/2011
• 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: 00070 YR