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

Catalog Number	RSINT35015UX
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: the hypotube had detached approximately 14cm distal to the strain relief.The hypotube was oval and jagged on both sides of the break site.The hypotube was kinked at approximately 32, 46.2, 77 and 91.9cm distal to the detachment site.The transition shaft and support wire were kinked.The distal inner and outer shafts were ripped extending 3.1cm from the guide wire entry port.There was deformation to the 15th stent wrap with struts raised.It was confirmed that the detachment occurred when placing the device in the biohazard bag for return.(b)(4).
Event or Problem Description
The physician was attempting to implant a resolute integrity stent.The target lesion located in the proximal lad was reported to be moderately tortuous, with no calcification and 100% stenosis.Procedure was prompted by stemi.Prior to the procedure, no damage was noted to packaging and no issues were reported when removing the device from the hoop/tray.The device was inspected and negative prep was carried out both with no issues reported.The lesion was pre-dilated.During attempted stent deployment, the stent was placed across the stenosis.Inflation of the balloon was attempted at 4-5atms for the first time but the balloon never inflated at all.When pulling negative on the stent delivery system, blood came back into the inflation device.The device was not passed through a previously deployed stent and no resistance was encountered when advancing the device.The device was not moved or repositioned in the lesion prior to the issue noted.The procedure was completed with another non-medtronic stent as no other resolute integrity was available in that size.No patient injury reported.
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: 6344928
• Report Number: 9612164-2017-00192
• Device Sequence Number: 10957633
• Product Code: NIQ
• UDI-Device Identifier: 00643169037113
• UDI-Public: 00643169037113
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/24/2017

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: 05/09/2018
• Device Catalogue Number: RSINT35015UX
• Device Lot Number: 0008046367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2017
• Initial Date Received by Manufacturer: 01/24/2017
• Supplement Date Received by Manufacturer: 01/24/2017
• Initial Report FDA Received Date: 02/21/2017
• Supplement Report FDA Received Date: 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1