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

Catalog Number ERES27518X

Device Problem Material Distortion (2977)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/29/2014

Event Type  malfunction  

Event Description

The physician was attempting to treat a lesion in the lad with an endeavor resolute drug eluting stent.The device was inspected prior to use with no issues noted.The lesion exhibited 75% stenosis, calcification and tortuosity.The lesion was pre-dilated; however the endeavor resolute stent could not pass the lesion.The physician used a new device to complete the surgery.The patient is good.No damage to the stent was reported, however, following evaluation of the returned device stent deformation was confirmed.Evaluation summary : the stent had moved distally on the balloon.The 1st distal stent segment was covering the distal marker band.Crimp impressions were evident on the exposed balloon portion.The 5th to 8th distal stent segments were raised and deformed.Please note that this device (endeavor resolute) is distributed outside the united states; however, it is similar to the united states distributed product (resolute integrity).

Manufacturer Narrative

Evaluation results: inherent risk of procedure (stent deformation).Patient condition affected effectiveness of the device (target lesion exhibited 75% stenosis, calcification and tortuosity).Deformation problem.Evaluation conclusion: known inherent risk of procedure (stent deformation).Device failure/lack of effectiveness related to patient condition device (target lesion exhibited 75% stenosis, calcification and tortuosity).(b)(4).

• Brand Name: ENDEAVOR RESOLUTE 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: 4039895
• MDR Text Key: 4864448
• Report Number: 9612164-2014-01140
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2015
• Device Catalogue Number: ERES27518X
• Device Lot Number: 0006629246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2013
• 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: 00069 YR