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

Model Number	RSINT22530UX
Medical Device Problem Codes	Difficult to Remove (1528); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/14/2018
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
During the procedure, an attempt was made to use one resolute integrity rx coronary drug eluting stent to treat a lesion in the lad.There were no abnormalities in relation to the anatomy.It was reported that difficulties were encountered when removing the device prior to stent deployment and the stent was never deployed.No patient injury was reported.
Additional Manufacturer Narrative
The lesion was very calcified and tortuous.The stent dislodged from the delivery system while bringing it back to the catheter.It was removed with the catheter and stent all at once.No patient injury was caused as a result of this event.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis summary: delivery system did not return for analysis.Deformation was evident to the stent wraps with the struts stretched and bunched.Dried blood was visible on the stent.Lot number confirmation was confirmed based on the returned stent matching the complaint.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.

• 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: 7872029
• Report Number: 9612164-2018-02378
• Device Sequence Number: 1720137
• Product Code: NIQ
• UDI-Device Identifier: 00643169037335
• UDI-Public: 00643169037335
• 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,Followup,Followup
• Report Date (Section B): 01/17/2019

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: 04/25/2019
• Device Model Number: RSINT22530UX
• Device Lot Number: 0008600092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2018
• Initial Date Received by Manufacturer: 08/14/2018
• Supplement Date Received by Manufacturer: 09/18/2018; 11/05/2018; 01/15/2019
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 10/15/2018; 12/03/2018; 01/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1