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	01/20/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the physician was attempting to use a resolute integrity drug eluting stent to treat a moderately calcified, 90% stenosis and tortuous lad lesion.The device was inspected before use with no issues noted.The lesion was pre-dilated.Some resistance was encountered during advancement of the stent, it was removed to further dilate the lesion.Excessive force was not used.It was reported that the stent was damaged due to the vessel tortuosity.The physician crossed with another resolute integrity stent.No patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Initial reporter phone number updated.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: 6328342
• Report Number: 9612164-2017-00173
• Device Sequence Number: 10928545
• Product Code: NIQ
• UDI-Device Identifier: 00643169037175
• UDI-Public: 00643169037175
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 07/11/2018

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: 09/27/2018
• Device Catalogue Number: RSINT30026UX
• Device Lot Number: 0008234292
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/20/2017
• Supplement Date Received by Manufacturer: 01/20/2017; 06/11/2018
• Initial Report FDA Received Date: 02/14/2017
• Supplement Report FDA Received Date: 09/28/2017; 07/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 88