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

Catalog Number	RSINT27512W
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/06/2017
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 was attempting to implant a resolute integrity stent in a lesion in the lad which had moderate calcification and tortuosity.No damage was noted to the packaging and there was no issues noted when removing the device from the hoop/tray.The device was inspected with no issues and negative prep was performed with no issues.The lesion was pre-dilated.The device passed through a previously deployed stent.Resistance was encountered when advancing the device.It was reported that the stent dislodged during removal after failed delivery.The dislodged stent remains in patient and no other stent was implanted.
Additional Manufacturer Narrative
Clarification of date of report 2017-06-06, omitted from previous report for this pe.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.
Additional Manufacturer Narrative
Updated from serious injury to malfunction.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE INTEGRITY OTW
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6688837
• Report Number: 9612164-2017-00856
• Device Sequence Number: 45725
• Product Code: NIQ
• UDI-Device Identifier: 00613994793492
• UDI-Public: 00613994793492
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 06/06/2017

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: 02/28/2019
• Device Catalogue Number: RSINT27512W
• Device Lot Number: 0008515628
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/06/2017
• Supplement Date Received by Manufacturer: 06/06/2017; 06/06/2017
• Initial Report FDA Received Date: 07/06/2017
• Supplement Report FDA Received Date: 07/06/2017; 07/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 88