MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS COMMANDER DELIVERY SYSTEM, 23MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9610TF23

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by our (b)(4) affiliate, during deployment of a 23mm sapien 3 valve, a leak at the handle of the delivery system was noted resulting in partial deployment of the valve.Post dilatation was performed and no paravalvular leak (pvl) was observed.There was no consequence to the patient.

Manufacturer Narrative

The delivery system was returned to edwards lifesciences for evaluation.During visual inspection, a break was noted on the balloon shaft distal to the y-connector.A leak was confirmed under the balloon shaft strain relief at the y-connector, which resulted from a complete break on the balloon shaft distal to the y-connector.In addition, a slight compression was observed on the flex catheter near the flex tip.No other abnormalities observed.The balloon shaft outer diameter (od) distal to the y-connector bond met specification.No manufacturing non-conformances were found which could have contributed to the reported complaint event.No ifu/training deficiencies were identified.A review of complaint history from (b)(6) 2015 to (b)(6) 2016 revealed other returned complaints confirmed for commander delivery systems leakage distal to the y-connector (all sizes).In addition, a review of complaint history for the month of (b)(6) 2016 revealed that the occurrence rate for the trend category of commander delivery system leakage exceeded the trend category control limits.All devices are 100% inspected by manufacturing and quality from the distal to proximal ends of the device under 2.85x minimum magnification for device damage (e.G.Kinks, cuts).Also, balloon catheters are 100% leak tested.The related manufacturing lot underwent product verification testing on a sampling plan, which included visual inspection, tensile testing of the y-connector/balloon shaft joint, and inflation and deflation time; all samples passed visual inspection.During tensile testing, the calculated tolerance limit was statistically above the lower specification limit.The complaint for delivery system leakage was confirmed as a break in the balloon shaft adjacent to the y-connector was observed.Although it is possible that the balloon shaft was bent, kinked, or pulled during the procedure to cause or propagate the observed damage, it is also possible that a potential manufacturing/design related issue may have also contributed to the complaint event.Due to the severity associated with balloon shaft fracture near the y-connector, and other similar confirmed complaints, a risk assessment was performed and corrective/preventative actions are being addressed through a capa.This unit was manufactured prior to the implementation of any changes.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM, 23MM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: frances preston ; 1 edwards way; irvine, CA 92614 ; 9492505190
• MDR Report Key: 5567750
• MDR Text Key: 42376391
• Report Number: 2015691-2016-01174
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: MN
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2018
• Device Model Number: 9610TF23
• Device Lot Number: 60298829
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2016
• 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