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

Catalog Number UNK-CV-GWY-INT-DES

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2017

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The physician intended to use an nc sprinter balloon catheter to treat a lesion in the ostium of the left main coronary artery.There were no abnormalities in relation to anatomy.The lesion was pre-dilated.The device passed through a previously-deployed stent.The device was being used to post-dilate a newly deployed medtronic stent (model unknown).It is reported that the balloon got stuck on the stent after the stent was deployed.The balloon was fully deflated prior to attempting to remove the device.The stent was then removed from the patient using the balloon catheter.It was reported that no force was used to remove the balloon.No further intervention was required to remove the balloon or the stent from the patient.No damage was reported to the stent upon its removal.No damage was done to the artery walls.No patient injury was reported.The balloon did not get stuck on the previously deployed stent during advancement before reaching the target stent.No further stenting was required.

Manufacturer Narrative

Additional information: the nc sprinter device was being used to post-dilate a new non-medtronic stent.If information is provided in the future, a supplemental report will be issued.

• 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: 7192846
• MDR Text Key: 97876178
• Report Number: 9612164-2018-00074
• 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: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK-CV-GWY-INT-DES
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2017
• Initial Date FDA Received: 01/16/2018
• Supplement Dates Manufacturer Received: 03/27/2018
• Supplement Dates FDA Received: 04/25/2018
• 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