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

Catalog Number	RSINT22514UX
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	01/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: there was a detachment on the transition tubing immediately proximal to the guidewire entry port.The transition tubing material was stretched and jagged at the detachment site.The transition tubing was kinked and stretched proximal to the detachment site.There was a kink on the distal shaft 3.3cm distal to the detachment site.Kinks were visible on the hypotube.(b)(4).
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 proximal rca lesion exhibiting 80% stenosis.No damage was noted to the device packaging and no issues noted removing the device from the hoop tray.The device was inspected with no issues noted.Negative prep was performed successfully.The physician pre-dilated the lesion.During the procedure, the device did not pass through a previously deployed stent.No resistance or excessive force used during delivery.It was reported that the stent was delivered with no issues.Sufficient time was given for the balloon to deflate prior to removing the device from the patient.During removal of the delivery system, over the wire, separated breaking into two pieces near where the wire exits the rapid exchange segment.One piece of the broken stent catheter was removed upon pull back out of the body and the other detached piece of the stent catheter remained in the guide catheter and when the guide catheter was removed from the body the remaining piece was taken out of the guide catheter.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: 6328291
• Report Number: 9612164-2017-00171
• Device Sequence Number: 10996056
• Product Code: NIQ
• UDI-Device Identifier: 00643169037410
• UDI-Public: 00643169037410
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/19/2017

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: 04/27/2018
• Device Catalogue Number: RSINT22514UX
• Device Lot Number: 0008032533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2017
• Initial Date Received by Manufacturer: 01/19/2017
• Supplement Date Received by Manufacturer: 01/19/2017
• Initial Report FDA Received Date: 02/14/2017
• 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: 72 YR
• Patient Weight: 118