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

Catalog Number	RSINT35012UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An attempt was made to use a resolute integrity drug eluting stent to treat a moderately tortuous, mildly calcified lesion in the ostium of the right coronary artery.There was no damage noted to the device packaging.There were no issues when removing the device from the hoop.The device was inspected with no issues.Negative prep was not performed.The lesion was not pre-dilated.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device and excessive force was not used.It is reported that stent dislodgement occurred during delivery to the lesion.The physician went to inflate the stent and then deflated the balloon and noticed that there was no stent.The lesion was at an angle and the physician had to bring the stent back into the guide several times due to lack of support, it is reported that this may be why the stent dislodged.No intervention was carried out.The physician scanned the patient from trunk to head but the stent could not be found.The patient is alive without injury.
Additional Manufacturer Narrative
Additional information: no difficulties were noted when removing the protective sheath from the device.The indeflator was in neutral position, during delivery of the device.The procedure was completed with another stent.If information is provided in the future, a supplemental report will be issued.
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: 7421492
• Report Number: 9612164-2018-00784
• Device Sequence Number: 13462540
• Product Code: NIQ
• UDI-Device Identifier: 00643169037106
• UDI-Public: 00643169037106
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P110013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2018

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: 08/12/2019
• Device Catalogue Number: RSINT35012UX
• Device Lot Number: 0008742241
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/15/2018
• Supplement Date Received by Manufacturer: 05/08/2018; 08/03/2018
• Initial Report FDA Received Date: 04/11/2018
• Supplement Report FDA Received Date: 06/06/2018; 08/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1