MAUDE Adverse Event Report: MEDTRONIC IRELAND INTEGRITY RX; STENT, CORONARY

Catalog Number	INT30030UX
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the physician intended to use an integrity rx coronary bare metal stent to treat a non-calcified and non-tortuous lesion.There were no abnormalities in relation to anatomy.There was no damage noted to packaging and no issues noted when removing the device from hoop/tray.The device was inspected with no issued identified.Negative prep was not performed.The device was not kinked and restraightened during use.The lesion was not pre-dilated.The device did not pass through a previously-deployed stent.Resistance was encountered when advancing the device and excessive force was not used during delivery.It was reported that the catheter fractured during advancement through the guide catheter.It was described that the stent catheter would not advance through the sheath so the device was pulled back out.The device never entered the patient's vessel, the device remained in the guide catheter and no components remained in the patient.Another device was advanced with no issue to complete the procedure.Patient status post procedure is alive with no injury.

• Brand Name: INTEGRITY RX
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7066207
• Report Number: 9612164-2017-01683
• Device Sequence Number: 10788471
• Product Code: MAF
• UDI-Device Identifier: 00613994798534
• UDI-Public: 00613994798534
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P030009
• 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): 11/29/2017

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: 05/05/2019
• Device Catalogue Number: INT30030UX
• Device Lot Number: 0008618062
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2017
• Initial Report FDA Received Date: 11/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1