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

Catalog Number	RSINT30022UX
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/22/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the physician was attempting to treat a severely tortuous and moderately calcified proximal lad lesion exhibiting 95% stenosis using a resolute integrity drug eluting stent.No damage noted to packaging.No issues noted when removing the device from the hoop/tray.Device inspected and negative performed with no issues noted.The lesion was pre-dilated.The device did not pass through a previously deployed stent.No resistance was encountered when advancing the device and no excessive force used.It was reported that the stent was successfully deployed and balloon deflated with no issues noted, but as the balloon catheter was withdrawn it seemed to "catch" on the distal end of the catheter.It was reported that with some persistence the balloon catheter was able to be pulled into the catheter, but the wire came with it, although the catheter remained in the aorta.The same wire was used to require the vessel and a second resolute was deployed distal to the first one with no issues noted on either deployment or removal of the second balloon catheter.On removal of the balloon from the stent no resistance encountered as the device was retracted over the guidewire.No damage was noted to the guidewire on removal from the patient.Same guide catheter was used to complete the procedure.
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: 6499437
• Report Number: 9612164-2017-00448
• Device Sequence Number: 16460753
• Product Code: NIQ
• UDI-Device Identifier: 00643169037168
• UDI-Public: 00643169037168
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P110013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2017

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: 11/04/2018
• Device Catalogue Number: RSINT30022UX
• Device Lot Number: 0008363783
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/22/2017
• Supplement Date Received by Manufacturer: 03/22/2017
• Initial Report FDA Received Date: 04/18/2017
• Supplement Report FDA Received Date: 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1