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

Model Number	RSINT30026UX
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	Occlusion (1984); ST Segment Elevation (2059); Thrombus (2101); Vascular Dissection (3160)
Date of Event	07/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The patient presented with stemi and thrombus.A 3.00x26 mm resolute integrity device was used to treat a moderately calcified lesion with 95% stenosis in the ostium of the left main to the proximal lad (artery diameter 4.00 mm, lesion length 26 mm).There was no damage noted to the device packaging.There were no issues noted when removing the device from the hoop.The device was inspected with no issues.Negative prep was performed with no issues.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device and excessive force was not used.The patient was put on dapt.It is reported that approximately one hour after the resolute integrity device was implanted, the patient had st event elevations, so the patient was brought back to the cath lab where the stented vessel was 100% occluded at the stent site.There was st elevation post stenting due to an exit dissection and an undersized, malapposed stent (the stent was too small for the vessel).It was reported that the stent was too small for the vessel and under expanded.The physician noted thrombotic apical occlusion and went back in with several balloons including non-compliant balloons, to post-dilate the stent to an estimated 4.50mm size.Two non-medtronic stents were then deployed distally to the lesion where the dissection was noted.Post-procedure there is no patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
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: 7718412
• Report Number: 9612164-2018-01858
• Device Sequence Number: 995745
• Product Code: NIQ
• UDI-Device Identifier: 00643169037175
• UDI-Public: 00643169037175
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P110013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2019
• Device Model Number: RSINT30026UX
• Device Catalogue Number: RSINT30026UX
• Device Lot Number: 0008607220
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/02/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 11/26/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 10/03/2018; 11/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR