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

Model Number	RONYX35034UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis #247959032:cines attached at pe level.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 in the proximal left anterior descending (lad) artery.The device was inspected, and negative prep was carried out prior to use with no issues noted.No resistance was noted when advancing the device and no excessive force was used.It was reported that when the stent was about to be deployed the stent moved.It was thought the device either moved or foreshortened more than would have been expected.As a result the proximal part of the lesion was missed by a few mm.It was decided not to use an additional stent to treat the missed section of the lesion.No patient injury reported.
Additional Manufacturer Narrative
The lesion was predilated.The physician assessed that the stent did not move, but did foreshorten.The balloon of the stent had not been inflated prior to the foreshortening.18atm pressure was used for stent deployment.The stent did not dislodge from the balloon prior to stent deployment.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Regulatory report: (b)(4).Aware date is the 01-nov-19.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Image analysis: stent foreshortening can be defined as the percentage by which the length of a stent decreases from its crimped state to its deployed state (when the balloon is retrieved from the stent).The images provided show a fully deployed stent in the proximal lad.No images were provided showing the stent pre-deployment or showing the characteristics by which the user determined that stent foreshortening had occurred.It is not possible to assess the allegation based on the images provided.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: 9353215
• Report Number: 9612164-2019-04835
• Device Sequence Number: 19429459
• Product Code: NIQ
• UDI-Device Identifier: 00643169557123
• UDI-Public: 00643169557123
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/11/2020
• Device Model Number: RONYX35034UX
• Device Catalogue Number: RONYX35034UX
• Device Lot Number: 0009030147
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/01/2019
• Supplement Date Received by Manufacturer: 11/01/2019; 11/01/2019; 01/21/2020
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 11/29/2019; 11/29/2019; 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1