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

Catalog Number	RSINT22522UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the physician was attempting to use a resolute integrity rx drug eluting stent to treat a slightly tortuous and severely calcified mid lad lesion exhibiting 85% stenosis.No damage noted to device packaging or issues were noted when removing the device from the hoop/tray.The device was inspected with no issues noted.The lesion was pre-dilated.During the procedure the device did not pass through a previously deployed stent.Resistance was encountered during delivery and excessive force was used.It was reported that after trying to unsuccessfully deliver the stent to the lesion, the stent was removed.Upon inspection it was noted that the stent may have become dislodged from the balloon.The physician commented that the stent was observed to by roughed up on the end and not centered on the balloon after removal due to no cross.Another resolute was used to progress the case.No patient injury occurred.
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: 6144245
• Report Number: 9612164-2016-01220
• Device Sequence Number: 19042892
• Product Code: NIQ
• UDI-Device Identifier: 00643169037434
• UDI-Public: 00643169037434
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/07/2016

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: 06/24/2018
• Device Catalogue Number: RSINT22522UX
• Device Lot Number: 0008109276
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/07/2016
• Supplement Date Received by Manufacturer: 11/07/2016
• Initial Report FDA Received Date: 12/05/2016
• Supplement Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 63