MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS COMMANDER DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS PERCUTANEOUSLY DELIVERED

Model Number 9600LDS23A

Device Problem Burst Container or Vessel (1074)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/07/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.H3 other text : the device has not been received for evaluation.

Event Description

As reported by the field clinical specialist, during a transfemoral tavr procedure, the 23 mm commander balloon ruptured at the end of inflation.The valve was well expanded and seated.No further balloon inflations were needed.The balloon was gently and successfully pulled back into the sheath and withdrawn from the patient's body.Upon inspection there was a small radial tear of the commander balloon but not fully circumferential.There were no patient injuries or complications.Per follow-up with the fcs, the perceived cause of the rupture was sharp calcium in the sinus of valsalva (sov).

Manufacturer Narrative

A supplemental mdr is being submitted for the completed engineering evaluation.The event reported is anticipated in the risk management documentation for transcatheter heart valve procedures.A previous investigation into this type of event is captured in an edwards lifesciences technical summary and applies to this complaint.Additional assessment of the failure mode is not required at this time.The device was not returned for evaluation.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Per the technical summary, the ifu, current risk mitigations include design and manufacturing controls, and training manuals have been reviewed, no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The technical summary establishes, through extensive complaint investigations, that balloon burst events during valve deployment have not been associated with device malfunctions or manufacturing nonconformances.Rather, the root cause for these events have been due to calcification in the landing zone or over-inflation of the balloon.In addition, the ruptured balloon profile may lead to withdrawal difficulty and/or component separation if excessive device manipulation is applied.Therefore, it is likely that these patient/procedural factors may have caused or contributed to the burst balloon during valve deployment.Review of the ifu and training materials is detailed in the technical summary and continues to provide adequate instructions on device use, risks, and precautions.In addition, review of manufacturing mitigations is captured in the technical summary, which are still in place.With no unique issues or concerns raised with this complaint, this event will be included in ongoing monitoring and trending.The balloon burst complaint was unable to be confirmed due to lack of device return or applicable imagery.Available information suggests calcification likely contributed to the event as the customer reported that the ''balloon ruptured at the end of inflation.'' the customer also stated, ''the perceived cause of the rupture was sharp calcium.'' the presence of calcification can create a challenging anatomy for balloon inflation.While the balloons are sufficiently designed and tested to ensure the burst pressure is at or above the rated burst pressure, calcified nodules can compromise the structure of the balloon wall via following mechanisms such as puncture, local overstretching, open cell impingement, or stress concentration.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.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is required.

Manufacturer Narrative

A supplemental report is being submitted for the completed engineering evaluation for the device returned.Sections b.2, b.4, g.3, g.6, and h.2 have been updated.Corrections have been made to h.6: type of investigation, investigation findings, investigation conclusion.An addition was made to h6: device code.The event reported is anticipated in the risk management documentation for transcatheter heart valve procedures.A previous investigation into this type of event is captured in an edwards lifesciences technical summary and applies to this complaint.Additional assessment of the failure mode is not required at this time.The device was returned for evaluation.During visual evaluation of the device, a longitudinal and radial balloon burst was observed on the working length of the inflation balloon.Evaluation of the returned product showed that the device conforms to specifications.Per the technical summary, through extensive complaint investigations, balloon burst events during valve deployment have not been associated with device malfunctions or manufacturing nonconformances.Rather, the root cause for these events have historically been due to calcification in the landing zone or over-inflation of the balloon.In addition, the ruptured balloon profile may lead to withdrawal difficulty and/or component separation if excessive device manipulation is applied.Review of the ifu and training materials is detailed in the technical summary and continues to provide adequate instructions on device use, risks, and precautions.In addition, review of manufacturing mitigations is captured in the technical summary.The complaint for balloon burst was confirmed based on the evaluation of the returned unit.Available information suggests calcification likely contributed to the event as the customer reported that ''balloon ruptured at the end of inflation.'' the customer also stated, ''the perceived cause of the rupture was sharp calcium.'' the presence of calcification can create a challenging anatomy for balloon inflation.While the balloons are sufficiently designed and tested to ensure the burst pressure is at or above the rated burst pressure, calcified nodules can compromise the structure of the balloon wall via following mechanisms such as puncture, local overstretching, open cell impingement, or stress concentration.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.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is required.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Type of Device: AORTIC 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: 18248981
• MDR Text Key: 329507286
• Report Number: 2015691-2023-17855
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9600LDS23A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female