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

Catalog Number	RSINT22512UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	10/12/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician used a 2.25 x 12mm resolute integrity rx drug eluting stent in a tortuous lesion.No issues were noted to the packaging and no physical anomalies were noted.Normal prep and procedural protocols were followed.It is reported that the stent came off the balloon in the patient's artery.It was noted the stent left the balloon without being deployed.The device remains implanted in the patient.The patient underwent lima cabg procedure in lieu of this procedure.Patient is currently doing well.The physician remarked that this event sped up the requirement of the lima cabg procedure but that the procedure was required regardless.

• 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: 7032133
• Report Number: 9612164-2017-01615
• Device Sequence Number: 799497
• Product Code: NIQ
• UDI-Device Identifier: 00643169037403
• UDI-Public: 00643169037403
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 11/15/2017

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: 06/17/2019
• Device Catalogue Number: RSINT22512UX
• Device Lot Number: 0008682409
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2017
• Initial Report FDA Received Date: 11/15/2017
• 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