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

Catalog Number	RONYX22508UX
Medical Device Problem Codes	Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	12/27/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician attempted to treat two moderately tortuous, moderately calcified lesions in the mid lad, the proximal lesion had 70% stenosis and the distal lesion had 90% stenosis.There were no abnormalities reported in relation to anatomy.Both lesions were pre-dilated with no issues.Negative prep was not performed.There was no damage noted to device packaging, and no issues were noted when removing the devices from the hoop/tray.The devices were inspected with no issues.A 2.5x15mm resolute onyx stent was attempted for use in the most distal lesion but it failed to cross so the physician deployed it in the more proximal lesion (pli 30).Further pre-dilation was performed and a 2.75x12mm resolute onyx was successfully deployed in the distal lesion.There was an 8mm gap between the two stents so the physician decided to deploy a third stent at the site.A 2.25x12mm resolute onyx (pli-20) was attempted but had difficulty getting through the first proximal stent, excessive force was used and when removed the stent struts were noted to be deformed.A ptca balloon was used to dilate the area.A 2.25x08mm resolute onyx (pli-10) device was attempted and was successful in reaching the gap between the two deployed stents despite resistance encountered and the use of excessive force during delivery.The device was kinked and re-straightened during use.The stent balloon was inflated to 12 atm and the physician observed blood in the line and the non-mdt indeflator was unable to hold the pressure as if the balloon had ruptured.Sufficient time was given for the balloon to deflate prior to attempting to remove the device from the patient.The physician attempted to remove the stent delivery catheter and upon retrieval it was noted that the catheter had fractured, leaving the distal portion inside the 6f launcher guide catheter and lad.The physician inserted a 2.0 x 12mm medtronic ptca balloon and inflated inside the guide catheter to trap the fractured stent catheter and it was then successfully removed from the patient with the guide catheter.No difficulties were noted prior to attempting to remove the device from the patient.No patient injury is reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Patient has a medical history of nstemi, copd, coronary disease, htn, chf.The physician attempted to treat two moderately tortuous, moderately calcified lesions in the mid lad, the proximal lesion had 70% stenosis and the distal lesion had 90% stenosis.There were no abnormalities reported in relation to anatomy.Both lesions were pre-dilated with no issues.Negative prep was not performed.There was no damage noted to device packaging, and no issues were noted when removing the devices from the hoop/tray.The devices were inspected with no issues.A 2.5x15mm resolute onyx stent was attempted for use in the most distal lesion but it failed to cross so the physician deployed it in the more proximal lesion (pli 30).Further pre-dilation was performed and a 2.75x12mm resolute onyx was successfully deployed in the distal lesion.There was an 8mm gap between the two stents so the physician decided to deploy a third stent at the site.A 2.25x12mm resolute onyx (pli-20) was attempted but had difficulty getting through the first proximal stent, excessive force was used and when removed the stent struts were noted to be deformed.A ptca balloon was used to dilate the area.A 2.25x08mm resolute onyx (pli-10) device was attempted and was successful in reaching the gap between the two deployed stents despite resistance encountered and the use of excessive force during delivery.The device was kinked and re-straightened during use.The stent balloon was inflated to 12 atm and the physician observed blood in the line and the non-mdt indeflator was unable to hold the pressure as if the balloon had ruptured.Sufficient time was given for the balloon to deflate prior to attempting to remove the device from the patient.The physician attempted to remove the stent delivery catheter and upon retrieval it was noted that the catheter had fractured, leaving the distal portion inside the 6f launcher guide catheter and lad.The physician inserted a 2.0 x 12mm medtronic ptca balloon and inflated inside the guide catheter to trap the fractured stent catheter and it was then successfully removed from the patient with the guide catheter.No difficulties were noted prior to attempting to remove the device from the patient.No patient injury is reported.No allegation against the launcher or the mdt ptca balloon used to remove the fractured cath.
Additional Manufacturer Narrative
Evaluation summary: the distal portion of the device transition shaft, distal shaft and balloon were not returned for analysis.The device returned with a detachment on the hypotube 70.5cm distal to the strain relief.The hypotube material was oval and jagged on the detachment site.Kinks were evident on the hypotube 68cm distal to the strain relief.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Image review: images confirm the presence of calcified diffuse disease in the mid to distal lad.Lesion are also present in the left main to proximal lad and in the proximal lcx.No images were provided showing the difficulties experienced with delivery of the 15mm stent to the distal lesion but it can be confirmed that it was deployed in the proximal vessel.Images show the multiple pre-dilations of the mid to distal lad followed by successful stent deployment.Further dilations were completed prior to deployment of the 8mm stent.This stent was post dilated and all three stents were post dilated after deployment resulting in good flow through the lad.A guideliner device was used to support he delivery and deployment of the balloons and stents.This confirms the difficult nature of the vessel morphology.Stents were also deployed in the lm to prox.Lad and in the proximal lcx.Post dilation activities occurred to ensure full stent deployments.No issues were observed with the use of balloons and stents in the lm/lcx and ramus arteries.The fracture of the hypotube was not visualised in the image as the range for the images did not capture this part of the catheter.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: 7208845
• Report Number: 9612164-2018-00111
• Device Sequence Number: 764076
• Product Code: NIQ
• UDI-Device Identifier: 00643169556690
• UDI-Public: 00643169556690
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/24/2018

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: 05/16/2019
• Device Catalogue Number: RONYX22508UX
• Device Lot Number: 0008634251
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/23/2018
• Initial Date Received by Manufacturer: 12/27/2017
• Supplement Date Received by Manufacturer: 03/06/2018; 03/06/2018; 04/26/2018
• Initial Report FDA Received Date: 01/22/2018
• Supplement Report FDA Received Date: 04/03/2018; 04/03/2018; 05/24/2018
• 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: 70 YR
• Patient Weight: 126