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

Catalog Number	RSINT25022UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the 18th , 19th and 20th distal stent wraps with struts raised and overlapping.Slight deformation was evident to the distal tip.A kink was visible on the distal shaft of the device at 21cm proximal to the distal tip.The inner lumen patency was not verified with a 0.015 inch mandrel and 0.014inch guidewire due to a kink in the distal shaft.Com code: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician used a resolute integrity drug eluting stent to treat a mildly tortuous, severely calcified lesion with 95% stenosis in the mid ramus artery.There was no damage noted to packaging and there were no issues when removing the device from the hoop.The device was inspected with no issues and negative prep was not performed.The lesion was pre-dilated and the device did not pass through a previously-deployed stent.Resistance was encountered when advancing the device and excessive force was used during delivery.It is reported that the physician had difficulty advancing coronary balloons across the lesion.The resolute integrity device encountered extreme resistance and was unable to cross the lesion due to the excessive calcification in the ramus.Upon removal from the body the stent was examined and was noted to be deformed on the proximal struts; stent deformation occurred in vivo during positioning.The procedure was completed using a 2.5x18mm resolute integrity rx device.No patient injury was reported.

• 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: 7002553
• Report Number: 9612164-2017-01541
• Device Sequence Number: 1496027
• Product Code: NIQ
• UDI-Device Identifier: 00643169037380
• UDI-Public: 00643169037380
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Report Date (Section B): 11/06/2017

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: 03/09/2019
• Device Catalogue Number: RSINT25022UX
• Device Lot Number: 0008529573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2017
• Initial Report FDA Received Date: 11/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1