MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 PULMONIC DELIVERY SYSTEM; PULMONARY VALVE PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number	9630PL29A
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is ongoing.H3 : device not returned.
Event or Problem Description
As reported by the field clinical specialist (fcs), during implant of a 29 mm sapien 3 valve with alterra in the pulmonic position, the pulmonic delivery system balloon burst upon full inflation of nominal volume.
Additional Manufacturer Narrative
A supplemental mdr is being submitted for additional information from a product investigation.The product was not returned; therefore, a no product return investigation was completed.As a device was not returned, visual inspection, functional testing, and dimensional testing were unable to be done.Imagery was not provided.Review of the work orders above did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.As no device was returned and there is no evidence to support a manufacturing/design defect potentially contributed to the complaint, a manufacturing mitigation review is not required.The edwards sapien 3 transcatheter pulmonary valve system with alterra adaptive prestent ifu was reviewed.No ifu/training 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.The complaints balloon burst was unable to be confirmed.Due to unavailability of the device, engineering was unable to be perform any visual, functional, or dimensional analysis.Therefore, a manufacturing non-conformance was unable to be determined.A review of device history record and lot history supported that a manufacturing non-conformance likely did not contribute to the reported events.A review of ifu/training materials revealed no deficiencies.As reported, 'during implant of a 29 mm sapien 3 valve with alterra in the pulmonic position, the pulmonic delivery system balloon burst upon full inflation of nominal volume.Per follow up from the fcs, the valve was successfully deployed with the delivery system, although post ballooning was done to ensure full deployment.There was minimal calcium.' the balloon burst could be potentially from multiple factors (i.E., interaction with prestent, additional inflation volume, malpositioned inflation balloon (causing constriction), balloon not fully uncovered, calcification.).While the balloons are sufficiently designed and tested for rated burst pressures is at or above their inflation pressure, such factors can compromise the structure of the balloon wall via following mechanisms such as puncture, local overstretching, open cell impingement, or stress concentration.With the limited information provided, a definitive root cause is unable to be determined; however, the possibility of adverse interactions between the balloon and 'minimal calcification' cannot be ruled out at this time.Due to limited information, a definitive root cause was unable to be determined as to what contributed to the balloon burst.Since no device problem was identified affecting distributed product, no pra or capas are required.Since no product non-conformances or ifu/training deficiencies were identified during evaluation, a product risk assessment escalation is not required.Since no edwards defects were identified, no corrective or preventative actions are required.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.
Additional Manufacturer Narrative
A supplemental mdr is being submitted for additional information from a follow up.Investigation is ongoing.
Event or Problem Description
As reported by the field clinical specialist (fcs), during implant of a 29 mm sapien 3 valve with alterra in the pulmonic position, the pulmonic delivery system balloon burst upon full inflation of nominal volume.The valve was successfully deployed with the delivery system, although bav was done to ensure full deployment.There was no patient injury.

• Brand Name: EDWARDS SAPIEN 3 PULMONIC DELIVERY SYSTEM
• Common Device Name: 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: 17097318
• Report Number: 2015691-2023-13543
• Device Sequence Number: 1907572
• Product Code: NPV
• UDI-Device Identifier: 00690103210873
• UDI-Public: (01)00690103210873(17)231221(11)2112212164136124
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P200015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/21/2023
• Device Model Number: 9630PL29A
• Device Catalogue Number: 9630PL29A
• Device Lot Number: 64136124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2023
• Supplement Date Received by Manufacturer: 06/13/2023; 07/27/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 06/28/2023; 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown