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

Catalog Number	RSINT22518UX
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the balloon returned deflated.No deformation to the balloon.The device returned with a detachment on the hypotube 0.1cm(1mm) distal to the strain relief.The hypotube material was oval and jagged on both sides of the detachment site.Contrast was visible throughout the inflation lumen.The inner lumen patency was verified with a 0.015 inch mandrel.Slight deformation to the distal tip.Image review: two photographs were received from the account.One photo showing the shelf carton label confirmed the device batch # as reported by the account.The second photo confirmed a detachment on the hypotube distal to the strain relief.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use a resolute integrity rx drug eluting stent to treat a lesion in a patient's mid lad which was moderately calcified and had 90% lesion stenosis.There were no abnormalities 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 with no issues identified.Negative prep was performed with no issues noted.The lesion was pre-dilated.The device did not pass through a previously-deployed stent.Resistance was encountered when advancing the device.Sufficient time was given to the balloon to deflate prior attempting to remove the device from the patient.It was reported that the delivery system catheter broke in half during removal post successful stent deployment, at the point where the delivery system connects to hub.Two additional inflations were required as the balloon was stuck during removal.It is assumed by the physician that it may have been due to the calcification.The balloon did not pull back as easily as it should have.There were no issues encountered when deflating the device.No intervention was needed to retrieve the device.The device was pulled out using it's own delivery system.The device was removed by backing out in a rapid exchange fashion.It was reported that everything was successfully removed after the stent was safely deployed.Patient status post procedure is alive with no injury.

• 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: 7120446
• Report Number: 9612164-2017-01958
• Device Sequence Number: 19154433
• Product Code: NIQ
• UDI-Device Identifier: 00643169037427
• UDI-Public: 00643169037427
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 12/15/2017

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: 05/19/2019
• Device Catalogue Number: RSINT22518UX
• Device Lot Number: 0008640018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2017
• Initial Report FDA Received Date: 12/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1