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

Catalog Number	RSINT25014UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/18/2017
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.The lesion was pre-dilated.It was reported that due to an acute bend and calcification of the target lesion, the stent could not cross the lesion.Due to multiple attempts to position the stent, stent struts got damaged.No patient injury reported for this event.
Additional Manufacturer Narrative
Additional information : the target lesion was in the distal lad which exhibited calcification with 70% vessel tortuosity and 90% stenosis.The device was inspected with no issues.It was reported that resistance was noted while advancing the device to the lesion but no excessive force was used.The physician completed the procedure by balloon angioplasty.No stent was implanted.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The account has stated the resolute integrity stent was not at fault.The event was as a result of the patient's condition and the physician's manipulation situation.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: 6645981
• Report Number: 9612164-2017-00766
• Device Sequence Number: 1123542
• Product Code: NIQ
• UDI-Device Identifier: 00643169037366
• UDI-Public: 00643169037366
• Combination Product (Y/N): N
• Initial Reporter Country: CJ
• PMA/510(K) Number: P110013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/27/2017

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: 09/17/2017
• Device Catalogue Number: RSINT25014UX
• Device Lot Number: 0007744119
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/18/2017
• Supplement Date Received by Manufacturer: 06/17/2017; 07/27/2017
• Initial Report FDA Received Date: 06/16/2017
• Supplement Report FDA Received Date: 07/14/2017; 08/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 72