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

Model Number	20000ISA
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Foreign Body In Patient (2687); Foreign Body Embolism (4439)
Date of Event	12/06/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem 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).
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 2015691-2022-10292
• Device Sequence Number: 17701753
• Product Code: NKM
• UDI-Device Identifier: 00690103216943
• UDI-Public: (01)00690103216943(17)230824
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P220003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2022
• Supplement Date Received by Manufacturer: 01/10/2023; 03/06/2023
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 01/13/2023; 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2022
• 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