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

Catalog Number RSINT30026UX

Device Problems Migration or Expulsion of Device (1395); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/22/2017

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: resolute integrity 3.0x26mm stent returned on balloon of trireme medical chocolate device.When trying to remove stent from balloon, resistance was encountered and stent could not be removed.Stent was stretched, bunched and deformed and extended distally past the distal tip.Upon visual inspection of the stent, the presence of the distal and proximal laser cut offs (lcos) were confirmed indicating that no break had occurred on the stent and the full stent was returned on the chocolate balloon.(b)(4).

Event Description

The physician was treating the mid lad- diagonal branch.The vessel had severe calcification, 90% stenosis and severe tortuosity; artery diameter 3.5mm.The physician implanted one resolute integrity 3.0 x 26mm drug-eluting stent in the 3rd diagonal vessel into the lad at the bifurcation.Multiple balloons were passed through the stent struts to pta the mid lad.Then multiple stents were attempted to be placed in the lad which resulted in 5 no crosses.One of the devices that did not cross was a second 3.5x26mm resolute integrity.During delivery of the second 3.5x26mm resolute integrity, resistance was encountered when advancing the device and the shaft broke.Excessive force was used during delivery and the device did pass through the previously deployed stent.The shaft of the device snapped in half but was removed from the patient using normal proceedings.Then a 3.5x20mm chocolate balloon catheter was passed through the stents struts to pta the mid lad.Upon removal of the chocolate balloon, one of the nitinol wires that make up the cage was caught in the first 3.0 x 26mm stent.It was reported that this caused the stent to fracture, and 2/3 of the stent became dislodged and was removed from the body by the nitinol wire of the chocolate balloon.The remaining 1/3 of the stent was left in the diagonal artery.An additional stent was placed back in to the diagonal bifurcation.It is reported that 4 medtronic stents also failed to cross the lesion during the procedure.The 5th stent that did not cross is the device reported for shaft broke.No patient injury was reported as a result of the event.

Manufacturer Narrative

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: 6430895
• MDR Text Key: 70738173
• Report Number: 9612164-2017-00322
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169037175
• UDI-Public: 00643169037175
• 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,Followup
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2018
• Device Catalogue Number: RSINT30026UX
• Device Lot Number: 0008234292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2016
• 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