MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS COMMANDER DELIVERY SYSTEM; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED

Model Number 9610TF29

Device Problems Burst Container or Vessel (1074); Difficult to Advance (2920)

Patient Problems Obstruction/Occlusion (2422); Foreign Body In Patient (2687)

Event Date 06/16/2021

Event Type  Injury  

Manufacturer Narrative

The device was discarded.Investigation is ongoing.This is one of two manufacturer reports being submitted for this case, this for the first delivery system.

Event Description

As reported by our affiliates in (b)(6), the patient underwent an implant of a 29mm sapien 3 valve, in pulmonic position by transfemoral approach through a 26 fr non-edwards sheath.Resistance was felt advancing the commander delivery system (ds) through the sheath due to the patient's anatomical tortuosity.During valve implantation, the delivery system balloon ruptured when valve was fully inflated with additional volume (+ 38ml).Due to balloon rupture, the valve was misplaced in the right pulmonary artery, occluding a lobar artery.A second delivery system was prepped and used in an attempt to bring the valve back into the intended position which was unsuccessful.The sapien 3 valve was surgically removed and replaced with a surgical valve.The surgery was successful.The patient was stable.

Manufacturer Narrative

This is one of two manufacturer reports being submitted for this case, this for the first delivery system.Please see related manufacturer report number 2015691- 2021-04049.The device was discarded, however imaging was returned for review.As the device was not returned, visual inspection, functional testing and dimensional inspection were not able to be performed.The complaints were unable to be confirmed with no applicable technical summary available.The procedural imagery was provided by the site, which showed pulmonary angiogram/conduit/tortuous anatomy.During valve positioning, the valve was slightly too distal towards rpa.The valve was able to be fully deployed, but misplaced in rpa.During the manufacturing process, all inspections are conducted on 100% of units, except in the case of product verification (pv) testing, where the tested units are chosen on a sampling basis.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.Ifu for commander delivery system, device preparation manual, and device training manual were reviewed.No ifu/training deficiencies were identified.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.The complaints were unable to be confirmed.However, no manufacturing non-conformance was identified during the evaluation.A review of the dhr, lot history and manufacturing mitigations did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of the ifu and training manuals revealed no deficiencies.As reported, ''during valve implantation, the delivery system balloon ruptured when valve was fully inflated with an extra volume'' as such it is possible the balloon was overinflated, subjecting the balloon to pressures high enough to cause the balloon to burst.As such, available information suggests that procedural factors (over inflation) may have contributed to the reported event.Per the complaint description, ''resistance was felt crossing the delivery system through the sheath due to the anatomical tortuosity''.Access vessel characteristics such as tortuosity can create a challenging pathway for delivery system insertion/advancement through the sheath.Tortuosity can create sub-optimal angles that can lead to non-axial alignment in the advancement of the delivery system.Available information suggests patient factors (tortuosity) could have contributed to the event.Since no product non-conformances or ifu/training manual deficiencies were identified, no escalation to a product risk assessment was required.Since no edwards defect was identified, no corrective or preventative actions are required.H3 other text : device discarded.

Manufacturer Narrative

An administrative review of 3500a forms posted on the maude database showed this manufacturer report was submitted with the incorrect common device name, product code and pma number.A correction to fields d2 and g3 is being submitted in this supplemental report.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• 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: 12148075
• MDR Text Key: 260948134
• Report Number: 2015691-2021-04048
• Device Sequence Number: 1
• Product Code: NPV
• UDI-Device Identifier: 00690103193008
• UDI-Public: (01)00690103193008(17)230112(10)63582966
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2021

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: 01/12/2023
• Device Model Number: 9610TF29
• Device Lot Number: 63582966
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/16/2021
• Initial Date FDA Received: 07/09/2021
• Supplement Dates Manufacturer Received: 09/17/2021; 11/29/2021
• Supplement Dates FDA Received: 09/20/2021; 12/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2021
• 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
• Patient Age: 41 YR
• Patient Sex: Male