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

Catalog Number	RSINT25018UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that a resolute integrity drug eluting stent device failed to cross a 90% stenosed lesion located in the mid circumflex artery.The stent became deformed with a bent strut during the attempted placement at an extreme angle.It was indicated that the procedure was completed using an nc balloon.No patient injury is reported.
Additional Manufacturer Narrative
The lesion was pre-dilated with a 2.0x15mm euphora balloon.The resolute integrity was unable to cross the lesion.The lesion was further dilated with the euphora balloon.The resolute integrity was reinserted, but was still unable to cross due to extreme bend/tortuosity in the vessel.The procedure was completed by ptca with an nc euphora balloon, and the lesion in the ramus was also successfully treated.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.
Additional Manufacturer Narrative
Additional information: the lesion was located in the mid cx artery and exhibited severe tortuosity and severe calcification.It is noted that there was extreme angulation of the anatomy.No damage was noted to packaging, no issues when removing the device from the hoop.Device was inspected and prepped with no issues.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device.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: 7662399
• Report Number: 9612164-2018-01625
• Device Sequence Number: 19424356
• Product Code: NIQ
• UDI-Device Identifier: 00643169037373
• UDI-Public: 00643169037373
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/05/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/12/2019
• Device Catalogue Number: RSINT25018UX
• Device Lot Number: 0008737165
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2018
• Supplement Date Received by Manufacturer: 08/09/2018; 10/30/2018; 10/30/2018
• Initial Report FDA Received Date: 07/04/2018
• Supplement Report FDA Received Date: 09/04/2018; 11/05/2018; 11/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 82