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

Catalog Number RONYX35038X

Device Problems Difficult or Delayed Positioning (1157); Inflation Problem (1310); Difficult to Remove (1528); Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problems Myocardial Infarction (1969); Patient Problem/Medical Problem (2688)

Event Date 12/04/2017

Event Type  Injury  

Event Description

On (b)(6) 2017, two resolute onyx drug eluting stent devices ((b)(4)) were used to treat a moderately tortuous lesion in the proximal rca.A right radial artery approach was used.There was no damage noted to device packaging.There were no issues when removing the devices from the hoop/tray.The devices were inspected with no issues.Negative prep was performed with no issues.The lesion was pre-dilated with a non-medtronic balloon.The first stent ((b)(4)) did not pass through a previously deployed stent, did not encounter any resistance when advancing and no excessive force was used.This device was deployed in the proximal rca with no issues.The second stent ((b)(4)) did pass through the newly deployed stent in the proximal rca, no resistance was encountered and excessive force was not used.This second stent ((b)(4)) did not inflate, to deploy distal to the first stent.24 atm of pressure had been applied to the device when it was determined that there were inflation difficulties.When the (b)(4) was being removed by a goose neck snare, it got caught on the first stent ((b)(4)) causing the first stent to dislodge.It is reported that the (b)(4) balloon did very partially inflate proximally and distally in the lesion and the stent seemed to have gone through initially on trying to remove it from the rca but it would not come through the launcher guide catheter and a goose neck snare was then used to remove the device.It was then discovered that something had happened the first stent ((b)(4)) as nothing was seen on fluoroscopy.An ivus catheter was used to check via the femoral artery but no stent was visible, and on screening both stents were seen in the right forearm but having felt resistance at this point, the stents were left in the forearm.The (b)(4) balloon had been removed through the radial sheath.Attempts were made to inflate the balloon outside the patient and the balloon still would not inflate despite using multiple inflation devices.A spiral dissection was observed in the rca.The patient was referred to the vascular surgeons, and the case was abandoned.The stents were surgically removed on the (b)(6) 2017.The patient suffered a right sided myocardial infarction following the procedure.A second attempt was made to inflate the (b)(4) balloon.The balloon inflated under pressurisation, but in an unusual manner.

Manufacturer Narrative

Correction: date of event.Additional information: patient medical history included hypertension and osteoarthritis of the knee.The patient presented with troponin positive acs, with inferior wall hypokinesia suggestive of an rca infarct.The patient had previous surgery for ovarian cancer.It was noted that the rca likely had a spontaneous coronary artery dissection (scad), with significant luminal obstruction.A severe residual deep wall dissection was observed distal to the stent, so a decision was made to deploy another stent overlapping distally.As an attempt was made to retrieve the stent (ronyx35038x), it became crumpled and deformed on the proximal end.The physician managed to pass a 1.5mm balloon distally through the stent (ronyx35038x) and again tried to use this to retrieve the stent without success.The strut of the original stent that had been deployed proximally got caught and this too was unravelled and pulled out.The patient sustained a significant right coronary artery territory myocardial infarction as a result of the complications from the stent failing to deliver.The vascular surgery occurred without further complication and there was no residual vascular injury to the arm.The patient is expected to make a full recovery.The patient from a cardiac perspective was stable, with an echo confirming an inferior mi but no further chest pain or haemodynamic instability.Patient status is reported as alive with injury.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis summary: upon return, stent was detached from delivery system.Stent was returned attached to an additional stent (pli-10) and a snare was returned.During initial analysis blood tissue was visible throughout both attached stents.Both stents and snare were placed in waterbath to disperse the blood.During visual analysis deformation was evident to the complete stent, with wraps appearing raised and bunched.It was not possible to detach both stents from one another.The delivery system returned with no damage evident during initial device review.The delivery balloon inflated and deflated normally.Minor kinks were evident on the returned device.There was no evident to suggest a kink had impacted inflation.The inflation lumen was flushed into filter paper, no particulate was observed.The exchange joint lumen was inspected under microscope with no issues identified.Crimp impressions were visible on the balloon during analysis.No deformation was evident to the distal tip.No other damage was evident along the catheter during analysis.Cine image review: the target lesion in the proximal rca was confirmed through image review.The spiral dissection was observed in the rca post pre-dilatation activities.The first stent (ronyx40038x) was deployed in the proximal rca with no issues.The reported dissection was observed distal to the stent and the second stent (ronyx35038x) was delivered through the newly deployed ronyx40038x stent.The balloon of the ronyx35038x partially inflated in a "dog-boned" fashioned on the proximal end resulting in partial expansion of the proximal stent.Stent dislodgement was observed and during attempts to removed the stent and delivery system from the vessel.When the ronyx35038x was being removed by a goose neck snare it got caught on the first stent causing the first stent to deform and dislodge, as reported from the account.The presence of stents in the forearm was confirmed from the images.Video review summary: video one provided shows two physicians attempting to inflate the balloon of the delivery system.The stent is not present on the balloon.The delivery system was not supported by a wire.No images were provided of immersion of the balloon in water at 37 degrees in order to condition the balloon.The physician pressurises the balloon to 12 atms, 16 atms, and 18 atms.But there is still no balloon inflation.Video two provided shows a physician preparing the delivery system.The stent is not present and the delivery system appears to have blood residue on the balloon and catheter shaft.The delivery system was not supported by a guidewire or mandrel during preparation and inflation attempts.At 1:13 on the images the dial of the inflation device is shown to have reached 18 atms when it suddenly loses pressure and stabilises at 14 atms.At this stage the balloon also starts to inflate.It is not possible to see the dial of the inflation device after this, but it is clear that the physician continues to pressurise the balloon and the balloon expands with no leaks or bursts evident.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: 7132938
• MDR Text Key: 95322387
• Report Number: 9612164-2017-02027
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2019
• Device Catalogue Number: RONYX35038X
• Device Lot Number: 0008707096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2017
• 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: 63 YR
• Patient Weight: 85