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

Catalog Number RSINT35018UX

Device Problems Improper or Incorrect Procedure or Method (2017); Appropriate Term/Code Not Available (3191)

Patient Problems Bradycardia (1751); Death (1802)

Event Date 03/08/2015

Event Type  Death  

Event Description

The physician was treating severe instent restenosis of the rca in the range of 70-80%.The lesion was not pre-dilated prior to the placement of the resolute integrity drug-eluting stent.The stent was deployed under 16 atms for 30 seconds.No issues were reported during or post stent deployment.The stent had been post dilated with a 3.75 non-compliant balloon, with no issues noted.The balloon was inflated under 18 atms for 30 seconds.Excellent angiographic results were reported.It was reported that cardiac resuscitation was required later that same day and the patient was returned to the cardiovascular lab.The resuscitation was unsuccessful and the patient died.Cause of death unknown.Procedural notes received: from the returned procedural notes it appears that no pre-dilations of the vessel were performed, which is advised in the instructions for use.The patient¿s heart rate varies from 75-95(bpm).However when the patient was returned to the cardiovascular lab, the patients heart rated was lower at 60(bpm).Images were present in the procedural notes, but are not clear enough to view.Review of the patients procedural notes show no issue which may have contributed to the death of the patient.

Manufacturer Narrative

(b)(4).Evaluation code results: failure to follow instructions (failue to pre-dilate lesion prior or use of resolute integrity stent) inherent risk of procedure (death) predisposed to event (patient's co-morbidities may have contributed to event) no results available since no evaluation was performed (stent remains in patient,images were present in the procedural notes, but are not clear enough to view) none- no device received for evaluation.Evaluation code conclusion: failure to follow instructions (lesion not pre-dilated prior to implantation of resolute integrity stent) known inherent risk of procedure (death) unable to confirm event (procedural notes have returned and viewed but are not signed off by the physician) device not returned (stent remains in the patient).(b)(4).

• Brand Name: RESOLUTE INTEGRITY 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: 4667083
• MDR Text Key: 5693148
• Report Number: 9612164-2015-00494
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2016
• Device Catalogue Number: RSINT35018UX
• Device Lot Number: 0007222190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2015
• Date Device Manufactured: 07/11/2014
• 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): Death; Required Intervention
• Patient Age: 42 YR
• Patient Weight: 149