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

Model Number	9630TA29A
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is in progress.A supplemental report will be submitted upon completion.
Event or Problem Description
Edwards received notification from a field clinical specialist that during a transapical tavr in an unknown surgical valve the certitude delivery system balloon ruptured after the 29 sapien 3 valve was fully inflated.As reported, there was a chunk of calcium in annulus.A balloon aortic valvuloplasty was not performed.There was no extra volume added to the balloon prior to the inflation.The inflation technique was slow.Nominal volume was used for inflation.A longitudinal and lateral tear of balloon was overserved.The delivery system was safely removed and there was no harm to the lv.There were no negative outcomes or patient injuries.The device is not available for return.
Additional Manufacturer Narrative
The device was not available to be returned for.Therefore, a no product return engineering evaluation was performed.The device history record (dhr) review did not reveal any manufacturing nonconformance issues that would have contributed to the event.The complaint of balloon burst was unable to be confirmed due to unavailability of the complaint device and relevant imagery.Since the device was not returned, engineering was unable to perform any visual, functional, or dimensional analysis, and therefore no manufacturing non-conformances were able to be identified.An existing edwards technical summary has been documented for root cause analysis on balloon bursts in a calcified landing zone.The technical summary provides a rationale as to why it is unlikely that a product defect or manufacturing non-conformance contributed to this type of event, including factors on why deployment of balloons on thv delivery systems are subject to increased risk of burst in a calcified landing zone.As reported, 'there was a chunk of calcium in annulus.' the presence of calcification can create a challenging anatomy for balloon inflation.While the balloons are sufficiently designed and tested for rated burst pressures well above their inflation 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.In addition, the technical summary outlines the extensive manufacturing mitigations in place to prevent this type of malfunction (visual and dimensional inspections, leak testing, and functional balloon burst testing that occurs with every manufactured lot).These inspections and testing further support that it is unlikely that a defect present in manufacturing contributed to the complaint.The technical summary also outlines the instructions for valve deployment.It should be noted that these mitigations are still in place.Review of available information suggests that patient factors (calcification) contributed to the balloon burst.Since no edwards defect was identified, no corrective or preventative action is required.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.

• Brand Name: EDWARDS CERTITUDE DELIVERY SYSTEM
• Common Device Name: 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: 13078471
• Report Number: 2015691-2021-07015
• Device Sequence Number: 4278379
• Product Code: NPT
• UDI-Device Identifier: 00690103201451
• UDI-Public: (01)00690103201451(17)220603(10)63198562
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P140031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2022

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: 06/03/2022
• Device Model Number: 9630TA29A
• Device Catalogue Number: N/A
• Device Lot Number: 63198562
• 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: 12/02/2021
• Supplement Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 12/23/2021
• Supplement Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2020
• 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: Male