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

Catalog Number	RONYX40012UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Intimal Dissection (1333); Patient Problem/Medical Problem (2688)
Date of Event	12/04/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician intended to use two resolute onyx drug eluting stent devices ((b)(4)) to treat a moderately tortuous, moderately calcified lesion in the ostium of a mammary graft.No issues were noted when removing the protective sheath.The (b)(4) was inspected with no issues however the (b)(4) was not inspected.Negative prep was performed with no issues for both devices.The lesion was pre-dilated.Resistance was encountered when advancing the devices.The inflation device remained on neutral pressure during the delivery of the devices.It is reported that both stents dislodged during delivery to /at the lesion.The first device ((b)(4)) was not removed from the patient.The stent was deployed at the lesion, using a 4.0 x 12 resolute onyx balloon and post-dilated.The second device ((b)(4)) was removed from the patient using a low profile balloon, a euphora rx 1.5 x 15.No patient injury is reported.
Additional Manufacturer Narrative
Image review: the images capture the moderately tortuous, moderately calcified lesion as reported by the account.The images capture the guidewire advancing distally in the lesion, pre-dilation is performed with two balloons, followed by stent im plantation.A dissection is noted prior to stent delivery.Complete stents lima coverage (full metal jacket) was performed.No images of the reported resistance encountered delivery, or the reported subsequent dislodgement were visible in the images provided.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: 7132893
• Report Number: 9612164-2017-02023
• Device Sequence Number: 1260601
• Product Code: NIQ
• UDI-Device Identifier: 00643169557154
• UDI-Public: 00643169557154
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/25/2018

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: 10/04/2019
• Device Catalogue Number: RONYX40012UX
• Device Lot Number: 0008822120
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 04/26/2018; 04/26/2018
• Initial Report FDA Received Date: 12/20/2017
• Supplement Report FDA Received Date: 05/22/2018; 05/25/2018
• 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: 64 YR
• Patient Weight: 93