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

Catalog Number	RSINT25022UX
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	06/23/2017
Type of Reportable Event	Serious Injury
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 to treat a mildly tortuous lesion in the proximal cx artery with 80% stenosis.It is reported that the patient has a calcified carina but severity is not listed.The lesion was pre-dilated.There was no damage noted to packaging.There were no difficulties with removing the stylette or protective sheath. there were no issues noted when removing the device from the hoop.The device was inspected with no issues.Negative prep was performed with no issues.It is reported that stent dislodgement occurred during removal following a failed delivery.Inflation device was neutral.  to remove the dislodged stent, it was snared from the profunda federal artery.
Additional Manufacturer Narrative
Additional information: resistance was encountered when advancing the device.The device did not pass through a previously deployed stent.The delivery system was discarded, but the stent is available for return evaluation summary: the stent was not present on the balloon but did return for analysis.Delivery system was not returned with the stent; therefore, analysis was not performed.Deformation was evident to the complete distal stent wraps, with struts badly stretched and damaged.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: 6773051
• Report Number: 9612164-2017-01010
• Device Sequence Number: 18864955
• Product Code: NIQ
• UDI-Device Identifier: 00643169037380
• UDI-Public: 00643169037380
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/26/2018
• Device Catalogue Number: RSINT25022UX
• Device Lot Number: 0008074703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Initial Date Received by Manufacturer: 07/11/2017
• Supplement Date Received by Manufacturer: 11/22/2017
• Initial Report FDA Received Date: 08/08/2017
• Supplement Report FDA Received Date: 12/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR