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

Catalog Number	RSINT35026UX
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2017
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE INTEGRITY RX
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6430880
• Report Number: 9612164-2017-00321
• Device Sequence Number: 18946146
• Product Code: NIQ
• UDI-Device Identifier: 00643169037144
• UDI-Public: 00643169037144
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P110013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/22/2018
• Device Catalogue Number: RSINT35026UX
• Device Lot Number: 0008188251
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/23/2017
• Supplement Date Received by Manufacturer: 02/23/2017
• Initial Report FDA Received Date: 03/24/2017
• Supplement Report FDA Received Date: 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1