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

Catalog Number ERES35038X

Device Problems Burst Container or Vessel (1074); Material Deformation (2976)

Patient Problem No Code Available (3191)

Event Date 12/01/2014

Event Type  Injury  

Event Description

A 3.50 x 38 mm endeavor resolute rx drug-eluting stent was being used to treat a lesion in the mid rca with complete (100%) stenosis.The physician was attempting to direct stent the lesion following thrombus suction.90% stenosis remained after the thrombus suction.It is reported that after positioning stent during balloon inflation the balloon failed to inflate completely, reaching a pressure of 10 atm, and the stent was not opposed to the vessel wall correctly.Inflation was attempted again but a leak was noticed.It is reported that the balloon ruptured at 12 atm.Stent deformation was also noted at this stage.It is reported that the stent was deployed using the original device balloon the patient was sent for emergency cabg procedure.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: failure to follow instructions (direct stenting); patient's condition affected effectiveness of device (90% stenosis); inherent risk of procedure (stent deformation); no results available since no evaluation performed (device not returned for analysis); none (device not returned for analysis).Conclusions: failure to follow instructions (direct stenting); device failure/lack of effectiveness related to patient condition (90% stenosis); inherent risk of procedure (stent deformation); unable to confirm complaint (device not returned for analysis).(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: 4355731
• MDR Text Key: 20120646
• Report Number: 9612164-2014-01736
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 12/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2016
• Device Catalogue Number: ERES35038X
• Device Lot Number: 0007220339
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2014
• Date Device Manufactured: 07/10/2014
• 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
• Patient Age: 00027 YR
• Patient Weight: 70