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

Model Number	RONYX35038UX
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	High Blood Pressure/ Hypertension (1908)
Date of Event	11/13/2019
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
A resolute onyx rx coronary drug eluting stent was used to treat a mildly calcified, severely tortuous lesion in the mid right coronary artery (rca).The device was inspected with no issues.Negative prep was performed with no issues.The lesion was pre-dilated with a non medtronic 2.5 x 12 device.The device did not pass through a previously deployed stent.Excessive force was not used.It was reported that the guide didn't sit well, everything was taken out and a launcher guide catheter was used with a non medtronic guide extension catheter.It was reported that the balloon ruptured at 12 atm and the stent did not fully expand.A 1.25 x 12 sprinter legend device and a 2.0 x 12 non medtronic device were then used and the stent was post dilated with a 3.5 x 15 nc.The patient became hypertensive after the rupture and was transported to ccu.No other patient injury was reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information received: patient became hypotensive and bradycardic requiring iv fluids and atropine (not hypertensive as previously reported).It was reported that there was a relationship between the balloon burst and the patient becoming hypotensive.The device was returned with blood visible in the balloon and inflation lumen.The balloon failed negative prep.On pressurisation of the device, liquid was observed exiting the balloon.The balloon failed to maintain pressure.Upon visual inspection of the device, there was a short longitudinal tear on the balloon material on the proximal end of the balloon.The balloon material was jagged and uneven at the tear site.No other damage evident to the remainder of the device.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: it was reported there was a sudden drop in balloon pressure after the rupture.It was reported there was a relationship between the balloon burst and the patient becoming hypertensive.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: 9325931
• Report Number: 9612164-2019-04756
• Device Sequence Number: 16798474
• Product Code: NIQ
• UDI-Device Identifier: 00643169557130
• UDI-Public: 00643169557130
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/13/2020

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: 09/17/2021
• Device Model Number: RONYX35038UX
• Device Catalogue Number: RONYX35038UX
• Device Lot Number: 0009926856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 11/15/2019; 01/10/2020; 02/06/2020
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 12/06/2019; 01/30/2020; 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR