MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEATH VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9600TFX29

Device Problem Nonstandard Device (1420)

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

Event Date 10/13/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is in progress.A supplemental report will be submitted.

Event Description

Edwards received notification from our affiliates in germany.As reported, this it was an implant case of a 29mm sapien 3 valve.During device preparation and before crimping, it was noticed that the green holding thread was hanging out of the valve.The procedure was successfully completed with another valve of the same model.The patient outcome was good.

Manufacturer Narrative

The device was returned for evaluation and an engineering evaluation was performed.The returned device was visually examined for any abnormalities and the following was observed: one (1) green thread attached to the crimped valve on c1.Upon expansion of the valve: the suture knots near to c1 and c2 were broken/damaged.Observation on c1: length of green thread/suture: approximately 12mm (left end) and 5mm (right end).Observation on c2: missing knot on both end sutures.No abnormalities observed on c3.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 complaint device anomaly during prep was confirmed through product evaluation and provided picture.A review of dhr, lot history, complaint history, and manufacturing mitigations did not provide any indications that a manufacturing non-conformance would have contributed to the complaint.Current manufacturing mitigations are in-place to detect and reject loose knot, loose stitch, damaged thread and incorrect knot tail length.In additional, there was reported any damage upon the valve out of the box or solution jar.A review of ifu/training materials revealed no deficiencies.As reported, ''during device preparation, it was noticed that the green holding thread was hanging out of the valve at first crimping step.'' per evaluation of the returned device, the suture knots near to c1 and c2 were broken.Moreover, the double square knot on c1 and c2 had missing and loose and broken strands were observed at c1 and c2, respectively.Per investigation conducted by the manufacturing site, it is unlikely that during the valve assembly process, the knot was damage, at incorrect position or loose.Additionally, as part of the manufacturing process, 100% units are visually inspected before and after holder attachment for loose knot and knot tail length.In this case, the hanging out green thread was observed after the first crimped; therefore, it was potentially damaged during the valve crimping handling, so the valve could be snagged on something with improper handling.As such, available information suggests that procedural factors (valve crimping handling) may contributed to the complaint event.No device or labeling problem was identified during the evaluation.Therefore, no further escalation (capa/scar/pra) is required.As precautionary, an awareness communication was performed emphasizing the important of in-process mitigation on anomaly component during manufacturing.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 SAPIEN 3 TRANSCATHETER HEATH VALVE
• 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: 18067342
• MDR Text Key: 327312420
• Report Number: 2015691-2023-17253
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9600TFX29
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2023
• 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