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

Catalog Number	RSINT22518UX
Medical Device Problem Codes	Leak/Splash (1354); Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Physician attempted to use a resolute integrity stent to treat a mid lad lesion with severe tortuosity and severe calcification.No damage was noted to packaging and no issues noted when removing the device from the hoop/tray.Device was inspected with no issues.Negative prep was performed with no issues.Lesion was pre-dilated.Device did not pass through a previously deployed stent.Resistance was noted when advancing the stent and excessive force was used during delivery.A guideliner was used during the procedure for support.It is reported that the balloon of the device ruptured when the catheter was being advanced around a 90 degree bend.No inflation was attempted.Patient is alive with no injury.
Additional Manufacturer Narrative
Kinks were evident along the hypotube.Blood and residue was visible in the balloon pillows and the inflation lumen.Numerous kinks were evident along the distal shaft.The transition tubing was kinked and damaged approx.0.6cm proximal to the guidewire entry port bond.The stent was positioned on the balloon between the marker bands as per specifications.Visual inspection could not detect a leak site on the device due to the presence of blood and contrast in the balloon and inflation lumen.The distal shaft was cut away immediately distal to the guidewire entry port.The distal section of the device was placed in the water bath to disperse the contrast and blood in the inflation lumen.The balloon was successfully inflated to 9atm and the stent was successfully deployed with no issues noted.Analysis did not detect the presence of a leak or burst.
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: 6427086
• Report Number: 9612164-2017-00310
• Device Sequence Number: 943118
• Product Code: NIQ
• UDI-Device Identifier: 00643169037427
• UDI-Public: 00643169037427
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 04/26/2017

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: 10/24/2018
• Device Catalogue Number: RSINT22518UX
• Device Lot Number: 0008347285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2017
• Initial Date Received by Manufacturer: 02/22/2017
• Supplement Date Received by Manufacturer: Not provided; 04/26/2017
• Initial Report FDA Received Date: 03/23/2017
• Supplement Report FDA Received Date: 05/11/2017; 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1