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

Catalog Number	RSINT25022UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
The physician intended to use a resolute integrity drug eluting stent to treat a severely calcified, severely tortuous lad lesion with (b)(4) stenosis.There are no abnormalities reported in relation to anatomy.No damage was noted to packaging, i.E.Shelf carton, hoop/tray and no issues noted when removing the device from the hoop/tray.No difficulties noted when removing the protective sheath.Prior to use and during inspection / prep, no issues were noted with the device when the packaging stylet and protective plastic sheath were removed.The device was inspected with no issues.Negative prep was performed with no issues.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device.Excessive force was used during delivery.The physician noted difficulty advancing the stent through the calcified lesion.The inflation device remained on neutral pressure during delivery of the device.After the catheter was removed, the stent was seen to be deformed and it was reported to have slipped off the balloon catheter after removal from the patient.A non mdt stent was then used, and the same issue occurred with the non mdt stent.The procedure was completed with simple poba.The patient is reported as alive, 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: 6809453
• Report Number: 9612164-2017-01144
• Device Sequence Number: 19272517
• Product Code: NIQ
• UDI-Device Identifier: 00643169037380
• UDI-Public: 00643169037380
• 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
• Report Date (Section B): 07/26/2017

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: 05/05/2019
• Device Catalogue Number: RSINT25022UX
• Device Lot Number: 0008615656
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2017
• Initial Report FDA Received Date: 08/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1