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

Catalog Number	RONYX22530UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	09/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 onyx drug eluting stent to treat a moderately tortuous, severely calcified ramus ostial proximal lesion with chronic total occlusion, moderate tortuosity and severe calcification there was no damage noted to packaging.There were no issues noted when removing the device from the hoop/tray.No difficulties noted when removing the protective sheath.The device was inspected post removal of the sheath with no issues.Negative prep was performed with no issues.The lesion was pre-dilated.The device did not pass through a previously-deployed stent.Resistance was encountered when advancing the device and excessive force was used.The inflation device remained on neutral pressure during delivery of the device.It is reported that the stent originally crossed the lesion successfully but had to be removed due to loss of imaging.The physician did not feel comfortable leaving the stent in position while the x-ray rebooted so he pulled the stent back.After the power had restored, the physician attempted to advance the stent and noted that the stent had dislodged from the delivery system.Several attempts were made to recapture the stent but were unsuccessful.The dislodgement occurred during removal from the patient.A second 4x18mm resolute onyx was placed to sandwich the dislodged stent in position in the proximal lad.No patient injury is reported.

• 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: 6954033
• Report Number: 9612164-2017-01469
• Device Sequence Number: 1228792
• Product Code: NIQ
• UDI-Device Identifier: 00643169556751
• UDI-Public: 00643169556751
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• 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
• Report Date (Section B): 10/17/2017

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: 06/07/2019
• Device Catalogue Number: RONYX22530UX
• Device Lot Number: 0008668134
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2017
• Initial Report FDA Received Date: 10/17/2017
• 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: 55 YR
• Patient Weight: 118