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

Catalog Number	RSINT22522UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the physician was attempting to use a resolute integrity rx drug eluting stent to treat a moderately calcified and tortuous mid cx lesion.No damage noted to packaging, and no issues noted during removal.The device was inspected and negative prep was performed with no issues noted.The lesion was not pre-dilated.It was reported that during the procedure, the device did not pass through a previously deployed stent.Resistance was encountered when advancing the device.During removal following failed delivery, it was reported that the device got stuck in the guide and the stent dislodged in the guide.The dislodged stent was removed.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: 6303163
• Report Number: 9612164-2017-00101
• Device Sequence Number: 18911468
• Product Code: NIQ
• UDI-Device Identifier: 00643169037434
• UDI-Public: 00643169037434
• 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): 01/09/2017

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: 08/13/2018
• Device Catalogue Number: RSINT22522UX
• Device Lot Number: 0008177317
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/09/2017
• Supplement Date Received by Manufacturer: 01/09/2017
• Initial Report FDA Received Date: 02/06/2017
• 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: 69 YR