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

Catalog Number	RSINT25012UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	11/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was attempting to use a resolute integrity des to treat a non- calcified and moderately tortuous lesion in the proximal rca.No difficulty removing the protective sheath.Negative prep was performed with no issues noted.The lesion was pre-dilated and there were no abnormalities in relation to anatomy.During the procedure the device did not pass through a previously-deployed stent.Resistance was encountered during delivery but no excessive force used.A non medtronic guide extension catheter was used.It was reported that the stent was being advanced past the proximal rca when the stent dislodged.The physician continued with the case and placed a non-mdt stent over it.The inflation device remain on neutral pressure.The patient left the cath lab in normal condition and no further injuries were reported post procedure.

• 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: 7078403
• Report Number: 9612164-2017-01706
• Device Sequence Number: 1297895
• Product Code: NIQ
• UDI-Device Identifier: 00643169037359
• UDI-Public: 00643169037359
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P110013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/09/2019
• Device Catalogue Number: RSINT25012UX
• Device Lot Number: 0008671574
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 12/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention