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

Catalog Number	RONYX40008UX
Medical Device Problem Codes	Device Damaged by Another Device (2915); Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); Vascular Dissection (3160)
Date of Event	09/19/2018
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
During the procedure an attempt was made to use one 4.0x8mm resolute onyx rx coronary drug eluting stent to treat a non-tortuous and non-calcified lesion located in the proximal left main artery.The 4.0x8mm resolute onyx was deployed in mid left main to cover a dissection.There were no abnormalities in relation to the anatomy.The device was inspected with no issues noted.Negative prep was performed with no issues noted.The lesion was pre dilated.The device did not pass through a previously-deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It was reported that stent embolization from left main artery occurred due to interaction with a non medtronic guide extension catheter.The stent was advanced through a 3.5 ebu medtronic guide catheter along with a 6f non-medtronic guide extension catheter.Upon removal of guide extension catheter, the stent dislodged and most of stent length was hanging in left coronary cusp while the distal edge of the stent was still barely inside ostia left main.A non-medtronic 5.0x15mm balloon had been advanced to expand and capture the stent and upon removal of catheter and guide extension catheter, the stent came off the wire and embolised to patients right superior gluteal artery.The dislodged stent remains in the patient.Left main dissection was repaired with a 5.0x18 resolute onyx successfully and patient is doing well.No patient harm was reported.
Additional Manufacturer Narrative
It was indicated that a dissection occurred during the initial attempt to advance the 4.0x8mm resolute onyx stent.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Correction: a 5.0 x 15 resolute onyx was deployed in the lm.Previously reported as a 5.0 x 18 resolute onyx.Patient weight (b)(6) ibs.If information is provided in the future, a supplemental report will be issued.
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: 7978287
• Report Number: 9612164-2018-02817
• Device Sequence Number: 16401344
• Product Code: NIQ
• UDI-Device Identifier: 00643169557147
• UDI-Public: 00643169557147
• 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
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/12/2019

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: 06/19/2020
• Device Catalogue Number: RONYX40008UX
• Device Lot Number: 0009194103
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/19/2018
• Supplement Date Received by Manufacturer: 10/18/2018; 02/08/2019; 02/08/2019
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 11/23/2018; 02/08/2019; 02/12/2019
• 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: 89 YR
• Patient Weight: 101