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

Catalog Number RONYX30022UX

Device Problems Activation, Positioning or Separation Problem (2906); Device Damaged by Another Device (2915); Material Deformation (2976)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 09/12/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

An attempt was made to use resolute onyx rx coronary drug eluting stents to treat lesion in the svg to cx (second marginal).The proximal portion had 80% stenosis.The distal svg graft had severe stenosis, approx.95%.Ballooning was done prior to the stent attempt.A 3.0x22mm resolute onyx drug eluting stent was deployed at 18atm and reinflated at 18atm.Following deployment attempts were made to pass a guide liner and guidewires however the devices could not cross.A euphora balloon was inflated at 12atm.It was suspected that the 3.0x22mm resolute onyx was causing the devices to ¿hang up¿ therefore further post dilation was performed with a non-medtronic nc balloon at 16atm.Patient had still good flow to the artery.An attempt was made to stent the svg anastomosis with a 2.0mm resolute onyx.The 2.0mm onyx failed to cross the distal lesion.When attempting to remove the 2.0mm onyx, as the stent approached the guide, the stent appeared to accordion at the proximal guide, and initially could not be retracted.The distal stent edge had been possibly flared and hung-up in the proximal svg stent.With moderate difficulty it was possible to carefully remove the 2.0mm onyx using the guide as support.It was then noted that the 3.0mm onyx appeared to be affected an/or possibly crushed by the high-pressure ballooning and it was felt that an additional stent would be needed.A 3.0x12mm resolute onyx was deployed at 14atm just at the proximal edge of the previous stent.Ivus demonstrated excellent apposition of the stent without dissection or distal embolization.It was felt that additional ballooning would be a risk, so the procedure was ended.No patient injury is reported.

Manufacturer Narrative

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

Manufacturer Narrative

Image review: regarding the vessel morphology, a svg to om completed covered with previous stent (¿full-metal jacket¿).Regarding the procedure, it was noted the guide catheter not axially aligned with the vessel.Lack of guide catheter support to perform distal procedure.Advancing the guidewire distally denoted difficulties.Mismatch lesion : stent is noted at the proximal end (lesion ¿8mm vs.Stent 22mm).Extension catheter and ¿buddy-wire¿ was attempted to improve support.Proximal stent under expansion was also noted.In principle, the more stents the more difficulties to cross and reach out distal segments.This is a case with ¿full-metal jacket¿ at the svg to om, with distal and proximal stenosis.During the whole procedure no guide catheter support was achieved, a mismatched lesion : stent was encounter proximally, which add the already long stent previously implanted and create more difficulties to cross.Additionally, the distal part was attempted with another long stent, which add more difficulties to cross (the longer the stent the more difficult to advance).Multiple attempt were performed to improve the situation (e.G.Guide-extension catheter, ¿buddy-wire¿, post-dilation) but none worked.Finally, a short stent was implanted proximally and ptca was distally completed.In conclusion, all those aforementioned element created an combination to impede the advancement and placement of the long distal stent.There was no evidence of the reported stent deformation in vivo from the angiographic or ivus images.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: 8159260
• MDR Text Key: 130169814
• Report Number: 9612164-2018-03594
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169557000
• UDI-Public: 00643169557000
• 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,Followup
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2020
• Device Catalogue Number: RONYX30022UX
• Device Lot Number: 0009022438
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2019
• Date Device Manufactured: 03/06/2018
• 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
• Patient Age: 65 YR
• Patient Weight: 120