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

Catalog Number	RSINT30015UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	04/05/2018
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
During the procedure an attempt was made to use one resolute integrity rx coronary drug eluting stent to treat a severely calcified and mildly tortuous lesion located in the mid left anterior descending (lad) artery, exhibiting 95% stenosis.There were no abnormalities in relation to anatomy.There was no damage noted to packaging.There were no issues noted when removing the device from the hoop/tray.The device was inspected with no issues.Negative prep was performed with no issues.A right radial approach was used.The lesion was pre-dilated.The device passed through a previously-deployed stent.Resistance was encountered when advancing the device.It was reported that during the delivery of the stent to the mid lad, the delivery catheter broke just distal to the luer/hub.The stent was not deployed, and the device was removed from the patient without issue.An attempt was made to use another resolute integrity rx coronary drug eluting stent to treat the same lesion.No damage was noted to packaging.No issues were noted when removing the device from the hoop.The device was inspected with no issues noted.Negative prep was performed with no issues noted.The lesion pre-dilated.The device passed through a previously-deployed stent.A great deal of resistance was encountered when advancing the device due to calcifications.Excessive force was used during delivery.Multiple unsuccessful attempts were made to advance the device through the lesion.When the stent was being removed to further pre-dilate the lesion, it was reported the stent became dislodged from the catheter as it was being retracted through a 3.0x15mm resolute integrity stent that had been successfully deployed in the proximal lad during the same procedure.Under cinefluoroscopy the stent was located and was subsequently deployed in the proximal lad using two euphora balloons and an nc euphora balloon.With no issues.Another resolute integrity stent was then successfully implanted in the mid lad.Patient status post-procedure is alive with no injury.
Additional Manufacturer Narrative
Additional information: no difficulties were noted when removing the protective sheath.The pressure syringe was in the neutral position as the stent was attempting to cross a prior placed stent.Upon attempting to remove the second stent the belief is that the struts from the prior stent snagged the stent being delivered, thus removing it from its delivery balloon.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: 7493637
• Report Number: 9612164-2018-01007
• Device Sequence Number: 1513337
• Product Code: NIQ
• UDI-Device Identifier: 00643169037502
• UDI-Public: 00643169037502
• Combination Product (Y/N): N
• Initial Reporter State: WY
• 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): 09/17/2018

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: 08/16/2019
• Device Catalogue Number: RSINT30015UX
• Device Lot Number: 0008756195
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/10/2018
• Supplement Date Received by Manufacturer: 05/09/2018; 09/13/2018
• Initial Report FDA Received Date: 05/08/2018
• Supplement Report FDA Received Date: 06/06/2018; 09/17/2018
• 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: 84 YR