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

Catalog Number	RSINT30026UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the stent was positioned on the delivery system balloon between the inner shaft marker as per specifications requirements.The 15th and 16th distal stent wraps were deformed with raised struts.It was not possible to load a 0.015 inch mandrel through the device, due to the presence of hardened blood in the device.(b)(4).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 patient presented to the emergency with chest pain and pre-operative diagnosis of nstmi with positive troponin but no ekg changes.It was reported that the physician was attempting to use a resolute integrity rx drug eluting stent to treat a mildly calcified and moderately tortuous mid cx lesion exhibiting 90-99% stenosis.No damage to device packaging and no issues removing device from hoop/tray.Device was inspected and negative prep performed with no issues noted.The lesion was crossed with a 0.014 inch guidewire and pre-dilated at 14 atm.The device did not pass through a previously deployed stent.Resistance was encountered during delivery but no excessive force used.It was reported that the device failed to cross the target lesion and stent deformation in vivo during positioning occurred.The lesion was again pre-dilated up to 12atm at multiple sites.The procedure was completed with further stenting with resolute integrity stents.There were no further events with the stents that were used to complete the procedure.There are no injuries reported.The patient's medications on discharge included plavix, aspirin and a statin and a low dose beta blocker.

• 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: 6901036
• Report Number: 9612164-2017-01341
• Device Sequence Number: 718635
• Product Code: NIQ
• UDI-Device Identifier: 00643169037175
• UDI-Public: 00643169037175
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 08/31/2017

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: 04/12/2019
• Device Catalogue Number: RSINT30026UX
• Device Lot Number: 0008580350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2017
• Initial 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: 71 YR