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

Catalog Number RONYX25015UX

Device Problem Defective Component (2292)

Patient Problem Intimal Dissection (1333)

Event Date 08/06/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A resolute onyx rx drug eluting stent was used to treat a moderate tortuosity, severely calcified lesion in the lad.The lesion was described as a total occlusion, non chronic, stemi at 100%.There was severe calcification throughout entire vasculature, chronically totalled rca.The device was inspected with no issues noted.Negative prep was performed with no issues.The lesion was pre dilated with a 2.5mm non-medtronic balloon.The device did not pass through a previously deployed stent.Resistance was encountered however excessive force was not used during delivery.With the assistance of a guide liner, stent was deployed across the lesion and dilated to nominal pressure (12 atm).It was reported that the stent appeared larger than expected.It was reported that a distal edge dissection was observed.The dissection was treated with a subsequent onyx stent (2.25 x 12mm) which was inflated to 10 atm.It was reported that there was attempt made at ivus but they were unable to get the ivus catheter past the stent.A second in -deflator was used to expand both the 2.5mm onyx stent delivery system and the 2.5mm pre dilated non medtronic balloon to compare the sizes of the two devices outside the body.It was observed that the onyx stent delivery balloon looked to be larger than the non -medtronic pre-dilated balloon.Post procedure quantitative coronary angiography was carried out to confirm the stent size.The measurements indicated a mean of 2.95 mm on the onyx balloon.Onyx compliance chart indicates a stent size of 2.55 mm at 12 atms (nominal).

Manufacturer Narrative

Device evaluation summary: a resolute onyx 2.5mm*15mm delivery system, a non-medtronic 2.5mm*15mm poba device and two non-medtronic inflation devices received for analysis.The pressure of the inflation devices received were verified with a calibrated pressure gauge and confirmed to be reading correctly when pressurised to 12 atm.The resolute onyx balloon was inflated to nominal pressure of 12 atm using an inhouse inflation device with no issues noted.The od measurements of the balloon were recorded using a snap gauge and confirmed to be within manufacturing specifications.The balloon was rotated 90° and measured again and found to be within specification.The resolute onyx balloon was then inflated to nominal pressure of 12 atm using the one of the inflation devices that was received for analysis, with no issues noted.The od measurements were recorded again using a snap gauge and confirmed to be within manufacturing specifications.The balloon was rotated 90° and measured again and found to be within specification.The resolute onyx balloon was then inflated to nominal pressure of 12 atm using the remaining inflation device that was received for analysis, with no issues noted.The od measurements were recorded again using a snap gauge and confirmed to be within manufacturing specifications.The balloon was rotated 90° and measured again and found to be within specification.The non-medtronic device was inflated in order to capture image of the two devices.Image review:images confirm the presence of a cto in the lad that was resolved with ballooning and stenting with two (2) stents.The dimensional measurements of the proximal stent was shown in the images as measuring 2.58mm.It was not possible to confirm or deny this measurement from the images as it was not possible to accurately measure the images on the screen.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE ONYX RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8868513
• MDR Text Key: 153523247
• Report Number: 9612164-2019-03245
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556805
• UDI-Public: 00643169556805
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/14/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 08/16/2020
• Device Catalogue Number: RONYX25015UX
• Device Lot Number: 0009284403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/06/2019
• Initial Date FDA Received: 08/07/2019
• Supplement Dates Manufacturer Received: 09/16/2019
• Supplement Dates FDA Received: 10/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention