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

Model Number 20000ISA

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Perforation of Vessels (2135); Foreign Body In Patient (2687); Foreign Body Embolism (4439)

Event Date 12/06/2022

Event Type  Injury  

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.

Event Description

Edwards received notification of a pascal in mitral position where the hcp was not satisfied due to implant system failure with the fingers of the implant system coming detached from the distal end of the implant catheter and staying on device.There were attempts made to snare fingers from implant resulted in it coming off device and a chase down the peripheral system.The 2nd pascal device was inserted, and leaflets grasped.When dr eleid dropped the clasps, the device closed at the same time which was observed on echo and fluoro.The device would not open upon rotating the paddle knob but appeared visually normal.When the leaflet insertion was checked, it appeared adequate.It was discussed to remove the device and md did not want to do that.The actuation wire was intact and still engaged in the distal nut.The md decided to deploy because of acceptable leaflet insertion and mr reduction.Sutures were removed with some difficulty.Actuation wire was removed without difficulty.However, when the md removed the actuation wire from the distal attachment to the proximal plate the implant catheter appeared to sever completely, leaving the nitinol fingers attached to the 2nd implant.The team decided to snare.The device fragment ended up in the external iliac.The vascular surgeon who was called in suspected a vessel perforation of the iliac due to blushing of contrast.However, no additional intervention necessary per physician, due to adequate blood flow and no obstruction distal to embolized fingers of the device.Mr went from moderate to severe 3+ to mild 1+.Patient was doing well and was released on (b)(6) 2022 with no plans for reintervention.Physician was not concerned with debris (finger comp) migrating further.

Event Description

No new event information.Supplemental report is being filed since user facility's voluntary medwatch was received from the fda and to link the user facility report number with edwards (manufacturer's) medwatch.User facility voluntary medwatch report number is (b)(4).

Manufacturer Narrative

No new event information.Supplemental report is being filed since user facility's voluntary medwatch was received from the fda and to link the user facility report number with our (manufacturer's) medwatch.User facility voluntary medwatch report number is (b)(4).The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.The following sections were updated: b4, b5, g3, h2 and h10.

Manufacturer Narrative

The complaint was confirmed with objective evidence via imaging and the returned complaint sample.Visual inspection of the complaint unit identified witness marks on the shaft, which suggested that torsional load was applied.Review of the complaint file did not indicate torque was applied but witness mark suggests that torque applied to the attachment fingers during device preparation or procedural use may have occurred.As part of the investigation, characterization of the shafts manufactured by te was performed and documented.Test results show that the manufacturing variation at te in addition to the torque applied to the attachment fingers by operators are potential root causes to finger detachment for this complaint.However, this was not determined to be the definitive root cause for this single event.A capa was referenced for this complaint as well.The device history record review was completed, and this device passed all manufacturing and sterilization inspections.There are no nonconformance's identified related to the complaint event.

• 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: 16040156
• MDR Text Key: 306068453
• Report Number: 2015691-2022-10292
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103216943
• UDI-Public: (01)00690103216943(17)230824
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 08/24/2023
• Device Model Number: 20000ISA
• Device Catalogue Number: 20000ISA
• Device Lot Number: 10004153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 01/10/2023; 03/06/2023
• Supplement Dates FDA Received: 01/13/2023; 03/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2022
• 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