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

Model Number	9630PL29A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Unspecified Vascular Problem (4441)
Date of Event	07/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is still ongoing.
Event or Problem Description
As reported by the field clinical specialist (fcs), during an alterra transfemoral tmvr procedure with a 29 mm sapien 3 valve, a vascular complication occurred upon removal of the pulmonic delivery system (pds).The pds was removed from the pa and into the ivc; however, the system was pulled so quickly that the team was not able to catch the fluro imaging to 'marry' the capsule to the tapered tip prior to device removal.This led to the tapered tip getting "caught" in the vessel and was unable to be removed.The capsule and part of the balloon was out of the patient's body, but the tapered tip remained stuck in the vasculature.The implanting physician enlarged the venotomy however the device still could not be removed.Vascular surgery was called to performed a cutdown for device removal from the femoral vein.The tapered tip and balloon were intact, and the patient remained hemodynamically stable throughout procedure.
Additional Manufacturer Narrative
Correction to h6 based on additional information.Note: this mdr was originally submitted within the 30-day timeline, but due to a technical issue experienced during the submission process, acknowledgment 3 was not received.The mdr was confirmed to be transmitted properly, as we received acknowledgement 1 and 2, but this issue could not be resolved through the esg help desk, so this mdr has been resubmitted.Please reference esg and cesub support reference numbers: (b)(6).The device was not returned to edwards lifesciences for evaluation, however, a device history record (dhr) review was done, and did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was performed and revealed no other complaints relating to the reported event were identified.The instructions for use/training manuals were reviewed for guidance/instruction involving the esheath and delivery system usage.Based on the review of the ifu/training manuals, 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.The complaints for withdrawal difficulty from vasculature 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.As reported, 'the pds was removed from the pa and into the ivc; however, the system was pulled so quickly that the team was not able to catch the fluro imaging to 'marry' the capsule to the tapered tip prior to device removal.Therefore, the capsule and part of balloon was out of patient body, but the tapered tip got 'caught' and remained stuck in vasculature.' as such, it possible the hasty withdrawal of the delivery system without the retraction of the capsule led to the difficulties with withdrawal.Due to limited information, a definitive root cause was unable to be determined.However, available information suggests that procedural factors (improper withdrawal technique) contributed to the withdrawal difficulty.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: 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: 15161576
• Report Number: 2015691-2022-07159
• Device Sequence Number: 5748279
• Product Code: NPV
• UDI-Device Identifier: 00690103210873
• UDI-Public: (01)00690103210873(17)230714(11)2107142163856029
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/14/2023
• Device Model Number: 9630PL29A
• Device Catalogue Number: 9630PL29A
• Device Lot Number: 63856029
• 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: 07/08/2022
• Supplement Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 11/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown