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

Catalog Number	RONYX22522UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	06/08/2018
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
One resolute onyx drug eluting stent was attempted to be used to treat a non-tortuous and severely calcified lesion located in the o stium-proximal circumflex artery.There was no damage noted to the device packaging.There were no issues noted when removing the device from the hoop.No difficulties noted when removing the protective sheath.The device was inspected with no issues.Negative prep was not performed.The lesion was pre-dilated.The inflation device remained on neutral pressure during delivery of the device.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device.Excessive force was not used.The stent was passed to the lesion multiple times post lesion prep and dilation.Positioning and crossing the lesion was difficult due to calcification.It was reported that during the final attempt to pass the stent to the lesion, the stent dislodged.The delivery system was removed and inspected and noted to no longer have the stent on the balloon.Pictures were taken and the stent was visually seen in the patient.The dislodged stent was not removed from the patient.The stent was moved into the best position possible for adequate deployment using multiple balloons, ranging in size from 1.20mm x 15mm to 2.25mm x 15mm.The stent was deployed and post dilated, allowing proper blood flow.Further stents were placed without issue to complete procedure.No patient injury is reported.
Additional Manufacturer Narrative
Product analysis summary: the stent was not present on the balloon and did not return for analysis.Crimp impressions were visible on the exposed balloon surface.The balloon folds were partially expanded.The inner lumen patency could not be verified with a 0.015 inch mandrel most likely due to hardened blood.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: 7661914
• Report Number: 9612164-2018-01608
• Device Sequence Number: 1979554
• Product Code: NIQ
• UDI-Device Identifier: 00643169556737
• UDI-Public: 00643169556737
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 10/17/2018

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: 10/05/2019
• Device Catalogue Number: RONYX22522UX
• Device Lot Number: 0008824233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Initial Date Received by Manufacturer: 06/08/2018
• Supplement Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 07/04/2018
• Supplement Report FDA Received Date: 10/17/2018
• 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: 58 YR
• Patient Weight: 61