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

Catalog Number	RONYX22534UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	02/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician intended to use a resolute onyx rx drug eluting stent to treat a severely tortuous and calcified lesion located in the mid obtuse marginal artery, exhibiting 95% stenosis.Multiple calcified areas with tortuosity was reported in relation to anatomy.There was no damage noted to packaging.There were no issues noted when removing the device from the hoop/tray.The device was inspected with no issues identified.The stent was inspected post removal of the protective sheath, with no issues noted.Negative prep was not performed.The lesion was pre-dilated.The device did pass through a previously-deployed stent.Resistance was encountered when advancing the device.Excessive force was not used during delivery.It was reported that the stent dislodgement occurred during delivery to/at lesion.It was described that the stent dislodged from balloon.Physician went through proximal part of stent and deployed then wire through a strut and the distal part of the stent was crushed towards vessel intima.No patient injury reported.
Additional Manufacturer Narrative
Still image review: two still images were provided for review.The images confirm the patient lesion condition of the target om lesion as reported by the account.The images do not capture the reported dislodgment.The reported stent dislodgment cannot be confirmed by the images provided.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE ONYX RX
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7377211
• Report Number: 9612164-2018-00587
• Device Sequence Number: 1710954
• Product Code: NIQ
• UDI-Device Identifier: 00643169556768
• UDI-Public: 00643169556768
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• 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
• Report Date (Section B): 08/13/2018

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: 09/28/2019
• Device Catalogue Number: RONYX22534UX
• Device Lot Number: 0008814338
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2018
• Supplement Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 03/28/2018
• Supplement Report FDA Received Date: 08/13/2018
• 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: 66 YR
• Patient Weight: 97