MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INFLATION DEVICE; SYRINGE, BALLOON INFLATION

Model Number 96402

Device Problem Inflation Problem (1310)

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

Event Date 08/24/2023

Event Type  malfunction  

Event Description

Per report received from japan, the patient underwent a transfemoral transcatheter aortic valve replacement (tavr) and received a 26 mm sapien 3 ultra resilia (s3ur) valve.When inflating the balloon of the commander delivery system (ds) to deploy the s3ur valve, resistance was felt, and a pressure gauge of an atrion inflation device (atrion) indicated 9-10atm.The valve was deployed with 1 ml less than nominal volume and landed 80:20 aortic/ventricular position as intended.The inflation time was the same as normal cases, and paravalvular leak (pvl) was mild.Post dilation was not performed due to the native valve calcification and the inflation resistance.After withdrawing the ds from the patient, the doctor inflated the balloon of the ds to check the ds and atrion.Inflation resistance was felt again and the atrion indicated 7-8atm.There was no patient injury or contrast medium leakage reported.Per follow-up information, the patient recovered without problems.

Manufacturer Narrative

Investigation is ongoing.The edwards inflation device commercialized in europe by edwards lifesciences is similar to the marketed device in the united states by atrion medical products, inc.Under 510k (k032840).H3 other text: not returned.

Manufacturer Narrative

A supplemental mdr is being submitted due to product evaluation findings.Sections b4, d9, g3, g6, h2, h3, h6: type of investigation, investigation findings, investigation conclusions and h10 has been updated.The device was returned to edwards lifesciences for evaluation.The visual inspection of the returned device revealed the following: device was kinked/twisted at the proximal balloon shaft of delivery system; the pressure gauge needle was in the zero position.The device was functionally tested and the following was observed: the returned atrion inflation device was tested with sample commander delivery system; atrion inflation device was able to meet inflation/ deflation time specification; the device was within gauge tolerance accuracy testing at 4, 14 and 30 atm; the device passed pressure leak testing, pressure decay testing and vacuum capability testing with no anomalies noted.Due to the nature of the complaint, no applicable dimensional testing was able to be performed.The complaint for "inflation difficulty" is not confirmed as the alleged physical defect is not present on the returned device.An engineering evaluation is not required.No evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.Current risk mitigations include design and manufacturing controls, ifu warnings and cautions, and physician training on how to deploy thv.The benefits of the device outweigh the risks associated with difficult or unable to inflate balloon, resulting in procedural delay.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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 INFLATION DEVICE
• Type of Device: SYRINGE, BALLOON INFLATION
• 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: 17786814
• MDR Text Key: 323899473
• Report Number: 2015691-2023-16063
• Device Sequence Number: 1
• Product Code: MAV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• 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: 11/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 96402
• Device Lot Number: 96402377
• 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: 08/24/2023
• Initial Date FDA Received: 09/21/2023
• Supplement Dates Manufacturer Received: 11/22/2023
• Supplement Dates FDA Received: 11/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2022
• 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 Age: 88 YR
• Patient Sex: Male
• Patient Weight: 51 KG