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

Catalog Number	RSINT30038UX
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the delivery system returned with the stent off the balloon.The stent did not return for analysis.The balloon folds were open and crimp impressions were slightly visible on the balloon working length.There was blood residue visible in the balloon.There was a kink on the distal shaft at 11mm distal to the guidewire entry port.The proximal inner shaft marker was located in the proximal balloon pillow.Negative prep was performed on the device and a steady stream of bubbles was observed in the syringe, indicating the presence of a leak.On pressurization of the device, a leak was detected on the distal shaft of the catheter.Visual inspection confirmed the presence of a short longitudinal tear on the distal shaft, at 34mm distal to the guidewire entry port.The shaft material was protruding outwards and was jagged/uneven.The distal shaft was cut back to visual inspect the inner shaft.There was a short longitudinal tear visible on the inner shaft.The shaft material was protruding outwards and was jagged/uneven.Sem analysis of the leak site on the inner and outer shaft confirmed the material was protruding outwards at the leak site.The characteristics of the leak site on the inner and outer shaft suggest that the damage may have occurred while loading a wire into the inner lumen.(b)(4).
Event or Problem Description
It is reported that an attempt was being made to use resolute integrity device in a rca lesion with no calcification or tortuosity.No damage was noted to the packaging.The device was inspected with no issues noted.The lesion was not pre-dilated.No resistance was encountered upon advancing the device and excessive force was not used.The device did not pass through a previously deployed stent.It was reported that the balloon would not hold pressure at 10atm during deployment.It was reported that the balloon seemed to be intact after removal however, blood was visible inside.A leak was suspected somewhere within the shaft.Post dilation was carried out with a with a nc medtronic balloon.No injury was caused to the patient.
Additional Manufacturer Narrative
Lesion exhibited 80% stenosis.Negative prep/purging was performed on the device prior to use with no issues noted.Device was not moved or repositioned in the lesion prior to the leak.Issues occurred on the first and only inflation.There was no drop in pressure.The resolute integrity drug eluting stent was implanted successfully.A nc euphora balloon was used to post dilate the resolute integrity stent.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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: 6174468
• Report Number: 9612164-2016-01297
• Device Sequence Number: 929718
• Product Code: NIQ
• UDI-Device Identifier: 00643169037205
• UDI-Public: 00643169037205
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 12/21/2016

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: 08/15/2018
• Device Catalogue Number: RSINT30038UX
• Device Lot Number: 0008179389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2016
• Initial Date Received by Manufacturer: 11/15/2016
• Supplement Date Received by Manufacturer: Not provided; 12/21/2016
• Initial Report FDA Received Date: 12/14/2016
• Supplement Report FDA Received Date: 01/18/2017; 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 81