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

Catalog Number	RONYX25026UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/28/2018
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
An attempt was made to use a resolute onyx rx coronary drug eluting stent to treat a lesion located in the distal right coronary artery (rca).The lesion exhibited moderate tortuosity and severe calcification with 95% stenosis.The device was inspected with no issues noted.Negative prep was not carried out.Step up pre-dilation was carried out.A guide liner was used to aid delivery.Resistance was encountered when advancing the device however excessive force was not used.The device did not pass through any previously deployed stent.It was reported that following failed delivery stent dislodgement occurred during pullback while entering the guide liner.The stent was removed with a snare.No patient injury was reported.
Additional Manufacturer Narrative
Device evaluation summary: the delivery system was not returned with the dislodged stent.Deformation was evident to the dislodged stent.Tissue was visible en twined within the stent.Lot number confirmed based on returned stent matching the reported event.Additional information: no difficulties noted when removing the protective sheath.A non-medtronic guideliner was used to aid delivery.The inflation device remained on a neutral pressure during delivery of the device.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: 9271366
• Report Number: 9612164-2019-04613
• Device Sequence Number: 129343
• Product Code: NIQ
• UDI-Device Identifier: 00643169556836
• UDI-Public: 00643169556836
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 12/02/2019

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: 11/21/2020
• Device Catalogue Number: RONYX25026UX
• Device Lot Number: 0009452595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Initial Date Received by Manufacturer: 10/29/2019
• Supplement Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 11/04/2019
• Supplement Report FDA Received Date: 12/02/2019
• 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: 84 YR