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

Model Number	RSINT22514UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Highly calcified lesion in the diagonal branch of the lad.The device was inspected before use with no issues noted.The device was prepped per ifu with no issues noted.The lesion was pre-dilated.The device did not pass through a previously deployed stent or cell of a stent.Resistance was noted when advancing the device to the lesion and excessive force was not used.No resistance was noted during withdrawal of the device.The dislodged stent was removed through the guiding catheter.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During a procedure an attempt was made to use one resolute integrity rx coronary drug eluting stent to treat a diagonal lesion.It was reported that the stent failed to cross the lesion.It was stated that the stent came off the balloon catheter inside the guide catheter when removing the device from the artery.The procedure was completed using another stent of the same size.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: 9754966
• Report Number: 9612164-2020-00875
• Device Sequence Number: 16716544
• Product Code: NIQ
• UDI-Device Identifier: 00643169037410
• UDI-Public: 00643169037410
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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,Followup
• Report Date (Section B): 04/02/2020

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: 03/26/2021
• Device Model Number: RSINT22514UX
• Device Catalogue Number: RSINT22514UX
• Device Lot Number: 0009664994
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 02/28/2020; 04/01/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 03/23/2020; 04/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1