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

Catalog Number ENSP25018X

Device Problems Difficult To Position (1467); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/23/2016

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the distal tip was damaged.The 1st and 2nd distal stent segments were deformed with numerous struts raised.The stent was positioned on the balloon between the inner shaft markers as per specifications.

Event Description

It was reported that the physician was attempting to use the endeavor sprint drug-eluting stent to treat a severely calcified and severely tortuous lad lesion exhibiting 90% stenosis.No abnormality noticed during inspection prior to use.The lesion was pre-dilated four times with a 2.0x20 balloon catheter at 14atm for 8 mins with 60% stenosis remaining.During the operation, resistance was encountered when advancing the stent, excessive force was not used.It was reported that the stent could not cross the lesion.The device was removed from patient and was replaced with another stent to complete the operation.The physician commented that the event was related to the patient's vessel calcification.No patient injury was reported as a result of the event.Device was received for analysis and stent was found to be deformed.

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: 5774733
• MDR Text Key: 48922244
• Report Number: 9612164-2016-00652
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2018
• Device Catalogue Number: ENSP25018X
• Device Lot Number: A007863960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2015
• 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 Age: 66 YR