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

Catalog Number	RSINT30018UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2018
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 an attempt was made to use a resolute integrity rx drug eluting stent to treat a non calcified and non tortuous proximal rca lesion.No damage to device packaging and no issues removing the device from the hoop/tray.It was reported that the device was not inspected.Negative prep was performed with no issues noted.The lesion was pre-dilated.During the procedure, the device did not pass through a previously deployed stent.No resistance was encountered while advancing the device and no excessive force used.It was reported that after the device entered the patient's body, it was noted that the stent was fractured.The stent was never deployed.The device was removed from the patient.A non-medtronic stent was then used.No patient injury reported.
Additional Manufacturer Narrative
Product analysis summary: the stent was positioned between the marker bands but not meeting specifications due to deformation of the proximal stent wrap.Deformation was evident to the 19th distal stent wraps with struts raised.No deformation was evident to the distal tip.The inner lumen could not be verified with a 0.015 inch mandrel most likely due to hardened blood in the guidewire lumen.Slight bends are evident on the shaft of the device which are consistent with coiling of the device for return.No other damage evident to the remainder of 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: 8221508
• Report Number: 9612164-2019-00073
• Device Sequence Number: 18915954
• Product Code: NIQ
• UDI-Device Identifier: 00643169037151
• UDI-Public: 00643169037151
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/06/2019

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: 04/28/2019
• Device Catalogue Number: RSINT30018UX
• Device Lot Number: 0008607524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 01/07/2019
• Supplement Report FDA Received Date: 02/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 72