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

Catalog Number	RSINT25018UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/14/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a physician attempted to implant a resolute integrity rx drug eluting stent in the proximal rca-with moderate tortuosity, severe calcification and 80% stenosis of a patient.There were no anatomical abnormalities reported and the patient's medical history specified there were no known allergies.No damage was noted to the packaging and there were no issues noted when removing the device from the hoop.There were no difficulties noted when removing the protective sheath.The device was inspected with no issues reported.Negative prep was not performed.The inflation device remained on neutral pressure during delivery of the device.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device.No excessive force is reported to have been used.Stent dislodgement during removal is reported to have occurred following failure of device to cross the lesion.It is unknown if the stent dislodged inside or outside the body.No injury is reported to have been caused to the patient.Patient returned 2 days later and a pci was performed on the proximal rca using a non-mdt device.
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: 6248826
• Report Number: 9612164-2017-00047
• Device Sequence Number: 10997383
• Product Code: NIQ
• UDI-Device Identifier: 00643169037373
• UDI-Public: 00643169037373
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/19/2016

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: 06/22/2018
• Device Catalogue Number: RSINT25018UX
• Device Lot Number: 0008107501
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/19/2016
• Supplement Date Received by Manufacturer: 12/19/2016
• Initial Report FDA Received Date: 01/13/2017
• Supplement Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 64