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

Catalog Number RSINT25018UX

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2016

Event Type  malfunction  

Event Description

It was reported that the physician was attempting to use a resolute integrity rx drug eluting stent to treat a moderately calcified and moderately tortuous proximal lad lesion exhibiting 80% stenosis.No damage noted to device packaging and no issues were noted when removing the devices from the hoop/tray.No issues noted removing the protective sheath.The device was inspected and negative prep performed with no issues noted.It was reported that the lesion was not pre-dilated.The device did not pass through a previously deployed stent.No resistance was encountered advancing the device and no excessive force used.During stent deployment the resolute integrity stent seemed to jump forward when the physician inflated the balloon to 16atm.A non-mdt guidewire was used and the stent was post dilated using a nc euphora to post dilate.No clinical sequelae reported.

• 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: 6188606
• MDR Text Key: 62850807
• Report Number: 9612164-2016-01336
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169037373
• UDI-Public: 00643169037373
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2017
• Device Catalogue Number: RSINT25018UX
• Device Lot Number: 0007644289
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2016
• Date Device Manufactured: 07/11/2015
• 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