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

Catalog Number	RSINT22518UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/04/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The physician intended to use a resolute integrity drug eluting stent to treat a lesion located in the mid -distal right coronary artery.The lesion was reported to be severely tortuous and moderately calcified with 99% stenosis.No damage was noted to packaging and no issues noted when removing the device from the hoop/tray.There were no issues removing the sheath.The device was inspected with no issues.Negative prep was not performed.The lesion was pre-dilated.It was reported that during the procedure, the stent became loose during advancement to the lesion.The inflation device remained on neutral pressure during delivery of the device.The physician was able to remove the stent from the patient as it was on the catheter.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device and excessive force was used.
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: 6603987
• Report Number: 9612164-2017-00643
• Device Sequence Number: 16436752
• Product Code: NIQ
• UDI-Device Identifier: 00643169037427
• UDI-Public: 00643169037427
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/04/2017

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: 10/24/2018
• Device Catalogue Number: RSINT22518UX
• Device Lot Number: 0008347285
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2017
• Supplement Date Received by Manufacturer: 05/04/2017
• Initial Report FDA Received Date: 06/01/2017
• Supplement Report FDA Received Date: 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1