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

Catalog Number	RSINT27508UX
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	11/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Com code: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician intended to use resolute integrity rx drug eluting stent to treat a lesion.There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging.There were no issues noted when removing the device from the hoop/tray.The device was inspected before use with no issues noted.The device did not pass through a previously-deployed stent.Resistance was encountered when advancing the device.Excessive force was not used during delivery.It was reported that the physician felt resistance when initially advancing stent through guide.He then removed system and noticed a fracture in the proximal shaft of the catheter.The device broke in two.It was mentioned that the detached portion of device does not remain in patient and was removed through guide.The stent balloon was not inflated.Patient status post-procedure is alive with no injury.
Additional Manufacturer Narrative
Device analysis: detachment visible on the hypotube, 58.5cm proximal to the distal tip.The hypotube material was oval and jagged on both sides of the detachment site.Kinks were evident on the distal shaft proximal to the distal tip.Slight deformation to the distal tip.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: 7120694
• Report Number: 9612164-2017-01966
• Device Sequence Number: 1799151
• Product Code: NIQ
• UDI-Device Identifier: 00643169037533
• UDI-Public: 00643169037533
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 03/01/2018

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: 03/27/2019
• Device Catalogue Number: RSINT27508UX
• Device Lot Number: 0008552982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Initial Date Received by Manufacturer: 11/27/2017
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 12/15/2017
• Supplement Report FDA Received Date: 03/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1