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

Catalog Number	RONYX45026UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	03/21/2018
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 drug eluting stent to treat a severely tortuous, severely calcified lesion with 95% stenosis in the mid rca.There was no damage noted to the device packaging.There were no issues noted when removing the device from the hoop.No difficulties were noted when removing the protective sheath.The device was inspected with no issues.Negative prep was performed with no issues.No difficulties were noted when loading the device onto the guidewire.The lesion was pre-dilated.The device did not pass through a previously deployed stent.The inflation device remained on neutral pressure during delivery of the device.Resistance was encountered when advancing the device.Excessive force was not used.The stent met resistance at the distal part of the lesion and as the doctor pulled back the stent the non-mdt guide backed out into a non coaxial position.The guide went back into the aorta and pulled the stent back and the proximal edge of the stent caught the non coaxial tip of the guide catheter and knocked the stent off.3/4 of the stent balloon was still in the stent so the physician inflated the balloon.The displaced dislodged stent was deployed in the proximal - ostial rca, proximal to the target lesion.A 2.0x15mm euphoria, 3.0x15mm euphoria and a 4.0x12mm nc euphoria were used to deploy the rest of the stent.The lesion was pre-treated with a non-mdt atherectomy device at low speed for 4 runs, 25 secs long.The target lesion was treated with a 4.0x26mm resolute onyx through the previously deployed 4.5mm stent.The entire stented area was post dilated with 4.0mm and 4.5mm nc euphoria balloons.No patient injury is reported.
Additional Manufacturer Narrative
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: 7435538
• Report Number: 9612164-2018-00803
• Device Sequence Number: 1339593
• Product Code: NIQ
• UDI-Device Identifier: 00643169557277
• UDI-Public: 00643169557277
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2018

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: 09/04/2019
• Device Catalogue Number: RONYX45026UX
• Device Lot Number: 0008781901
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/21/2018
• Supplement Date Received by Manufacturer: 09/14/2018
• Initial Report FDA Received Date: 04/17/2018
• Supplement Report FDA Received Date: 09/18/2018
• 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