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

Catalog Number ENSP30030UX

Device Problem Collapse (1099)

Event Date 10/01/2014

Event Type  Injury  

Event Description

A patient was implanted with an endeavor sprint rx drug eluting stent in (b)(6) 2010.Details reported stated that at the end of (b)(6) 2014 the patient had been experiencing constant fatigue and was subsequently hospitalized for four days.A cardiac catheterization was carried out which revealed a 95% blockage in a coronary vessel, allegedly caused by the collapse of the endeavor sprint that had been previously implanted in 2010.A new stent was placed overlapping the collapsed stent.No subsequent complications are reported.

Manufacturer Narrative

Evaluation, results: inherent risk of procedure (stent collapse, restenosis).Patient¿s condition (predisposed event).No results available since no evaluation performed (device or procedural images not returned for evaluation).Conclusions device failure/lack of effectiveness related to patient condition (predisposed event).Inherent risk of procedure (stent collapse, restenosis).Unable to confirm complaint (device or procedural images not returned for evaluation).(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: 4349415
• MDR Text Key: 19797116
• Report Number: 9612164-2014-01726
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P060033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2011
• Device Catalogue Number: ENSP30030UX
• Device Lot Number: 0001199134
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2014
• Date Device Manufactured: 11/18/2009
• 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