MAUDE Adverse Event Report: EDWARDS LIFESCIENCES COMMANDER DS WITH SAPIEN 3; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED

Model Number 9750CM26A

Device Problems Burst Container or Vessel (1074); Difficult to Remove (1528); Material Separation (1562)

Patient Problem Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 11/17/2021

Event Type  Injury  

Event Description

As reported by field clinical specialist, this was a placement of a sapien 3 valve in the pulmonic position in a pre-existing surgical valve.A stent placed inside surgical valve covering landing zone.The stent was then ballooned with a 26mm balloon.The 16fr esheath was placed in rfv for valve delivery.A 26mm sapien 3 ultra was prepped and positioned within desired landing zone.The balloon ruptured during deployment just prior to full volume in balloon.The distal portion of the commander was caught on the outflow of the stent frame.It was noticed on fluoro that an apiece of the palmaz stent frame had become bent inward due to interaction with commander during attempted retrieval.Commander was centralized and was able to be removed.Commander was unable to be pulled back beyond the tricuspid valve.Multiple maneuvers attempted to retrieve commander but were ultimately unsuccessful.It was visibly evident by fluoro that the balloon portion was getting caught within the tricuspid valve.The decision was made to cut the proximal portion of the balloon catheter of the commander just distal to the y connector, telescope the pusher catheter over top of the balloon catheter, and eventually remove the esheath, swapping it for a large bore sheath to retrieve the balloon that was most likely flowered from the attempted retrieval.After circumferentially cutting the catheter and starting to pull back on the pusher catheter the system successfully came back through the tricuspid valve and into the ivc.The team attempted to pull the whole unit into the esheath when the outer shaft of the balloon catheter became detached from the inner wire lumen.The pusher and outer balloon catheter were removed from the e-sheath and the proximal 2/3rd's of the balloon were present.The inner balloon catheter shaft with the nose cone and other portion of the balloon were still inside the ivc.Lfv access obtained with a large bore sheath and the wire and distal portion of the inner balloon catheter were snared.Wire was externalized through the lfv sheath and the inner balloon catheter shaft was retrieved through the lfv sheath.The two pieces were put back together and the balloon appeared to be complete but it was hard to say for sure.Tee performed and the pt appeared to have moderate tr (patient was noted to have mild/moderate tr on a prior echo).New thv was performing as desired and no effusion was noted.Ivc was inspected and was noted to be normal in appeared.Pulmonary angiogram showed excellent valve function with no leak or damage to native surrounding anatomy.Access sites closed resulting in optimal hemostasis.The patient remained hemodynamically stable throughout the procedure.They did not add any extra volume prior to inflation.The device was discarded, no additional photos are available, no procedural imaging is available.The site does not perform ct reviews for the pulmonic procedures, so a 3mensio is not available.

Manufacturer Narrative

Investigation is ongoing.Device discarded.

Manufacturer Narrative

Medical records were received that provided patient's medical history.Update to a2, a3, b4, b7, g3, h2, h10 to reflect new information.There is no additional information provided from the documents.Investigation is ongoing.

Manufacturer Narrative

The device was discarded before it could be returned to edwards lifesciences.As the device was not returned, no visual inspection, functional testing or dimensional testing could be performed.No photos was available.A 3mensio was not available.No extra volume was added to the balloon prior to the inflation.Per angiography: there is moderate calcification of the rv to pa conduit and limited pulmonary valve leaflet mobility.With a 24mm atlas balloon inflated in the conduit there is no coronary nor aortic root compression following pulmonary valve replacement, the conduit diameter is larger and there is no pl and no extravasation of contrast.Imagery was provided from site and showed the delivery system burst balloon post procedure.System shows no guidewire lumen assembly with in the balloon shaft.The work orders related to the manufacturing of the devices and components that could potentially contribute to the complaint did not reveal any manufacturing non-conformance issues that would have contributed to the complaint event.During the manufacturing process, multiple visual inspections and tests are performed throughout the process.All inspections are conducted on 100% of units, except in the case of product verification (pv) testing, where the tested units are chosen on a sampling basis.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.The following ifu and training manuals were reviewed for guidance and instruction on device preparation and procedural use of the commander delivery system: ifu commander delivery system with s3 thv, pulmonic, device preparation training manual, pulmonic position, and procedural training manual, pulmonic position.Based on the review of the ifu and training manual, no deficiencies were identified.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.Since no product non-conformance was confirmed, a product risk assessment (pra) is not required.Since no edwards defect, which could have resulted in the complaint, was confirmed, no preventative or corrective actions are required.The balloon burst, and balloon and tip separation were confirmed by the provided imagery.However the withdrawal difficulty was unable to be confirmed as neither the complaint device nor applicable imagery were provided for evaluation.Due to the unavailability of the device, engineering was unable to perform any visual, functional, or dimensional analysis.Therefore, a manufacturing non-conformance was unable to be determined during the evaluation.Additionally, a review of the device history record, lot history, and complaint history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of the ifu and training manuals revealed no deficiencies.Regarding the balloon burst, the complaint description reports the procedure occurred ''in the pulmonic position in a pre-existing surgical valve.'' additionally, ''the balloon ruptured deployment just prior to full to volume in balloon.'' while the balloon is sufficiently designed and tested for the rated burst pressure well above their inflation pressure, it is possible that the interaction between the balloon and the struts of the degenerating pre-existing valve can compromise the structure of balloon wall, even at low implantation pressures, through mechanisms such as puncture, local overstretching, open cell impingement, or stress concentration.As such, available information suggests that patient factors (pre-existing valve) may have contributed to the reported event.As reported, ''the distal portion of the commander was caught on the outflow of the stent frame.It was noticed on fluoro that an apiece of the palmaz stent frame had become bent inward due to interaction with commander during attempted retrieval.Commander was centralized and was able to be removed.Commander was unable to be pulled back beyond the tricuspid valve.Multiple maneuvers attempted to retrieve commander but were ultimately unsuccessful.'' the balloon burst likely altered the balloon profile.The altered balloon material likely made it more susceptible to be caught on the pre-existing valve/stent during withdrawal, subsequentially resulting in the reported withdrawal difficulty.Additionally, ''the team attempted to pull the whole unit into the esheath when the outer shaft of the balloon catheter became detached from the inner wire lumen.The pusher and outer balloon catheter were removed from the e-sheath and the proximal 2/3rd's of the balloon were present.The inner balloon catheter shaft with the nose cone and other portion of the balloon were still inside the ivc.'' with the altered balloon material, likely further exacerbated from withdrawing burst balloon from pre-existing valve/stent, made the distal portion of the delivery systemmore susceptible to be caught on the sheath tip, further contributing to the reported withdrawal difficulty.Additional pull force and excessive manipulation likely was applied to overcome the withdrawal difficulty, which likely resulted in the reported separation.Available information suggests procedural factors (withdrawal of burst balloon, excessive manipulation) could have contributed to the event.The complaint description states, ''the distal portion of the commander was caught on the outflow of the stent frame.It was noticed on fluoro that an apiece of the palmaz stent frame had become bent inward due to interaction with commander during attempted retrieval.Commander was centralized and was able to be removed.'' the altered balloon material likely made it more susceptible to be caught on the pre-existing valve during withdrawal.Furthermore, a non-coaxial guidewire can interact with the patient's anatomy or pre-existing devices, which may have resulted in the delivery system's interaction with surgical valve upon withdrawal.As such, available information suggests that procedure factors (withdrawal of burst balloon, malpositioned guidewire) may have contributed to the reported event.3 the ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.Per the instructions for use (ifu), cardiovascular injury of valvular structures [e.G., injury to the tricuspid valve/ apparatus] are known potential complications associated with the overall thv procedure.In some cases, intervention may not be required; however, if the injury is significant it typically results in profound tricuspid regurgitation and will require intervention to prevent permanent injury.Physicians are extensively trained by edwards before they are qualified to use the sapien transcatheter heart valve (thv).Training includes proper guidewire positioning and careful manipulation of devices.If entanglement is suspected, the guidewire should be completely removed from the ventricle; the operator should change the direction of the needle and reinsert the guidewire into the ventricle, checking again for wire entanglement.The tf training manual also provides guidance for valve crossing and wire exchange: exchange 0.035'' amplatz extra-stiff wire with the pre-shaped distal end in the right ventricle.Ensure guiding catheter is advanced upon wire exchange to ensure exchange wire does not get caught in the tricuspid chordae.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results suggest/indicate (withdrawal of burst balloon, malpositioned guidewire) caused or contributed to this event.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of this adverse event is not required at this time.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.

• Brand Name: COMMANDER DS WITH SAPIEN 3
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 12981482
• MDR Text Key: 286499337
• Report Number: 2015691-2021-06776
• Device Sequence Number: 1
• Product Code: NPV
• UDI-Device Identifier: 00690103207835
• UDI-Public: (01)00690103207835(17)230804(10)63926416
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2022

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: 08/04/2023
• Device Model Number: 9750CM26A
• Device Catalogue Number: 9750CM26A
• Device Lot Number: 63926416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2021
• Initial Date FDA Received: 12/10/2021
• Supplement Dates Manufacturer Received: 12/28/2021; 01/24/2022
• Supplement Dates FDA Received: 01/18/2022; 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2021
• 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: 37 YR
• Patient Sex: Male