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

Model Number 20000ISM

Device Problem Particulates (1451)

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

Event Date 09/28/2022

Event Type  Injury  

Manufacturer Narrative

The event is captured by edwards lifesciences under complaint #: (b)(4).Once the product is received and evaluated, the investigation findings code will be updated.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 precision ace procedure in the mitral position.During the procedure, a structure resembling a thrombus on echo was observed on the device after introducing it in the left atrium.The activated clotting time (act) was checked and confirmed to be within the therapeutic range.It was decided to take out the device and remove the structure with it.After the bailout, it was observed that a "white small thin structure" on the tip of the implant was no thrombus.As reported, it could not be ruled out that it came from the inner coating of the guide sheath (gs), so a new gs and implant system (is) were used.The procedure ended successfully.The is, the gs, and a sample container with the white structure were kept being sent back for evaluation.There is no report of patient harm or injury.

Manufacturer Narrative

The event is captured by edwards lifesciences under complaint #: (b)(4).The following sections were updated/corrected: b1, b2, b4, d4, g3, g6, h1, h2, h3, h4, h6, and h10.H10: a supplemental mdr is submitted based on corrected data and the manufacturer's device evaluation.Particulate on the patient contacting surface of the device entering the vasculature, resulting in embolization and/or infection or the risk for embolization/infection cannot be excluded.Upon further review, this is considered a serious injury, and the risk is not remote.The implant system, guide sheath, and a small container with the foreign white material were returned to edwards lifesciences for evaluation.The particulate was identified as collagen type i and determined to have been tissue from the patient.The patient's condition and procedure history do not indicate any risk of tissue tearing.Based on a review by ew representatives, the tissue most likely came from the transseptal puncture site and is an adverse event labeled in the ifu.No manufacturing non-conformances were confirmed to be related or contributed to the complaint event.Therefore, no ifu/training deficiencies were identified, and no corrective/preventative actions were required.

Manufacturer Narrative

The event is captured by edwards lifesciences under complaint #: (b)(4).The following sections were updated/corrected: b4, d9, g3, g6, h2, h3, h6, and h10.A preliminary evaluation of the returned particulate determined it was collagen.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: PASCAL PRECISION SYSTEM
• 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: 15620534
• MDR Text Key: 304705812
• Report Number: 2015691-2022-08636
• Device Sequence Number: 1
• Product Code: NKM
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2023
• Device Model Number: 20000ISM
• Device Catalogue Number: 20000ISMA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/28/2022
• Initial Date FDA Received: 10/17/2022
• Supplement Dates Manufacturer Received: 10/26/2022; 12/20/2022
• Supplement Dates FDA Received: 11/17/2022; 12/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2022
• 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): Other