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

Catalog Number	RONYX50015UX
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	04/25/2018
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 resolute onyx rx coronary drug eluting stent to treat a mildly tortuous and non-calcified lesion located in the proximal right coronary artery (rca).There were no abnormalities in relation to the anatomy.There was no damage noted to the device packaging.There were no issues when removing the device from the hoop/tray.The device was inspected with no issues noted.Negative prep was performed with no issues.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.It was reported that the balloon only half deployed at nominal pressure (12 atm) and after the balloon was removed it was noted that the stent only half deployed.The inflation difficulty was not due to due the vessel morphology.The same inflation device was used with other devices pre and post inflation difficulties.It was reported that multiple nc euphora balloon catheter devices were used to finish deploying the stent.It is also reported that multiple sizes of the nc euphora balloon catheter were unable to cross the lesion.Patient status is alive without injury.
Additional Manufacturer Narrative
Additional information: a 3.0x15 nc euphora did not cross the lesion and was re-inserted.A small balloon was used first to dilate the stent, and then larger balloons were used to dilate the stent to desired 5.0 diameter.A 4.0x8mm nc euphora would not cross after the 5.0 stent was implanted.The stent was post-dilated with a 2.5x12mm nc euphora.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The balloon returned deflated with crystalised residue in the balloon.The device was placed in the waterbath to disperse the residue in the balloon in order to aid inflation.The balloon failed negative prep.On pressurisation of the device, a leak was observed on the balloon distal cone.The balloon failed to maintain pressure.Upon visual inspection of the device, there was a longitudinal tear on the balloon material immediately proximal to the balloon distal cone.The balloon material was jagged and uneven at the tear site.Lead in scratches were evident proximal to the tear site.Deformation was evident to the distal tip.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Image review: photo 1; still image captured from film shows a balloon that appears to have been partially inflated at the proximal portion of the balloon.The mid and distal portion of the balloon appears to have not inflated.Blood is visible in the balloon.Photo 2; the stent is not present on the balloon; crimp impressions are visible on the balloon.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: 7532528
• Report Number: 9612164-2018-01177
• Device Sequence Number: 1652154
• Product Code: NIQ
• UDI-Device Identifier: 00643169557307
• UDI-Public: 00643169557307
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 10/18/2018

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: 11/06/2019
• Device Catalogue Number: RONYX50015UX
• Device Lot Number: 0008865449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Initial Date Received by Manufacturer: 04/25/2018
• Supplement Date Received by Manufacturer: 05/31/2018; 07/20/2018; 08/17/2018; 09/27/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 06/29/2018; 08/15/2018; 09/12/2018; 10/18/2018
• 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: 73 YR
• Patient Weight: 101