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

Catalog Number ENSP30018X

Device Problem Inaccurate Delivery (2339)

Patient Problem Vasoconstriction (2126)

Event Date 09/29/2015

Event Type  Injury  

Manufacturer Narrative

Product analysis: the stent was not present on the balloon.Balloon folds were open and residue was visible in the balloon indicating that the device was previously inflated.There was no other damage evident to the device.(b)(4).

Event Description

The physician was attempting to use an endeavor sprint drug-eluting stent.Nothing unusual was noted during device preparation.The device was inspected before use with no abnormalities noted.The target lesion in the distal rca had minor calcification, severe tortuosity and 80% stenosis.The lesion was pre-dilated with 60% stenosis remaining.Excessive force was not used during delivery of the endeavor resolute.It was reported that during the procedure the guide catheter 'bounced' during deployment.The stent was deployed in the distal part of the lesion as a result and did not cover the intended location.Another stent was replaced to complete the procedure.The physician determined the reason for the event was the severe vessel tortuosity.The procedure time was extended with the patient experiencing vasospasm.The physician determined that the vasospasm was related to the product.Current patient status is good and the patient has left the hospital.

Manufacturer Narrative

Corrected data: typo in event problem excessive force was not used during delivery of the endeavor sprint.

• 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: 5204590
• MDR Text Key: 30508915
• Report Number: 9612164-2015-01723
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P110013
• 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: 10/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2015
• Device Catalogue Number: ENSP30018X
• Device Lot Number: 0006961858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2013
• 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: 00065 YR