MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS PASCAL PRECISION; MITRAL VALVE REPAIR DEVICES

Model Number 20000ISM

Device Problems Device Damaged by Another Device (2915); Device-Device Incompatibility (2919)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/06/2024

Event Type  Death  

Event Description

Edwards received notification of a pascal precision ace procedure in mitral position where during the re-do repair procedure, the device was stuck and completely entangled between two mitraclips that were previously implanted.One non-edwards device was partially detached, and mitral regurgitation (mr) grade was 3.Device closing, retracting, rotating and implanting was not possible.Therefore, the procedure was immediately shifted to surgery with valve replacement.As reported the pascal was disconnected from the implant catheter (ic) being in elongated position.Some force was needed to retract the wire and close the device.Torsion was observed at the middle of the rest-catheter.Unfortunately, the patient did not overcome the surgery.

Manufacturer Narrative

The event is captured by edwards lifesciences under complaint #: (b)(4).The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.H3 other text : not returned.

Manufacturer Narrative

The presence of dislodging/disturbance of previously implanted devices as described in the complaint event was confirmed with objective evidence through procedural tee and images of product after surgical intervention.Based on review of investigation findings, potential contributing factors to the dislodging/disturbance of previously implanted devices are procedural conditions (using previous asd as non-optimal tsp, post-procedural mitraclip pca, targeted trajectory, incorrect maneuvers, insufficient landing zone, and pascal ace positioning between previously implanted mitraclip implants).The reported dislodging/disturbance of previously implanted devices event does not allege a malfunction that could be related to an edwards manufacturing deficiency, and one was not confirmed per imaging review of the explanted device.In addition, a dhr review was completed, and no nonconformances related to the complaint event were identified.

• Brand Name: EDWARDS PASCAL PRECISION
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: cassandra cook ; 1 edwards way; irvine, CA 92614 ; 5743778277
• MDR Report Key: 18994160
• MDR Text Key: 338824305
• Report Number: 2015691-2024-02410
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103213324
• UDI-Public: (01)00690103213324(17)250128
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P220003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: 20000ISM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2024
• 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
• Patient Outcome(s): Required Intervention; Death
• Patient Age: 81 YR
• Patient Sex: Male