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

Catalog Number	RONYX50012UX
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During a procedure an attempt was made to use a euphora rx ptca balloon catheter, an nc euphora rx ptca balloon catheter, and a resolute onyx rx coronary drug eluting stent to treat a non tortuous, severely calcified lesion in ostium of the left main (lm) coronary artery.The devices were inspected with no issues noted.Negative prep was performed with no issues noted.The lesion was pre dilated using a cutting balloon.The devices did not pass through a previously deployed stent.Resistance was not encountered during delivery of the nc euphora and the resolute onyx devices.Excessive force was not used during delivery of all three devices.It was reported that all three devices burst when inflated to 12 atm.The resolute onyx burst during stent deployment.One inflation had been applied to the resolute onyx prior to the burst.No patient injury reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The resolute onyx stent needed to be post-dilated after the burst occurred.The same non-medtronic inflation device was used with all three medtronic devices.The devices were not moved or repositioned prior to the burst.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The account stated no serious injury occurred.The account stated all three medtronic products burst during the intervention.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: 8690543
• Report Number: 9612164-2019-02286
• Device Sequence Number: 11246682
• Product Code: NIQ
• UDI-Device Identifier: 00643169557291
• UDI-Public: 00643169557291
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/29/2019

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: 12/10/2020
• Device Catalogue Number: RONYX50012UX
• Device Lot Number: 0009486963
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 06/24/2019; 08/30/2019; 10/26/2019
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 07/22/2019; 09/25/2019; 10/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 55