MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS COMMANDER DELIVERY SYSTEM, 26MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9600LDS26A

Device Problems Break (1069); Fracture (1260); Mechanical Problem (1384); Physical Resistance/Sticking (4012)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 08/08/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported, during a pulmonic case via transvenous approach, the delivery system got stuck in the patient¿s inferior vena cava (ivc) filter.The device was removed and replaced.Prior to the transcatheter pulmonary valve replacement (tpvr) case, the patient¿s ivc filter was observed to have a broken/fractured wire on the fluoro images.The sheath was inserted through the ivc.During balloon alignment the "fractured wire" could not be seen.At the same time, the valve and delivery system were getting caught, most likely got stuck on the broken wire of the ivc filter.The physician was unable to advance the delivery system or release the wire.The delivery/valve was removed as a unit without incident.A new delivery system and valve were ultimately prepped and delivered to the intended location and deployed without incident.The ivc appeared to be compromised but stable after the procedure.It didn't look "the same" after the delivery system was removed.The ivc was left in place, as it was confirmed there was no harm to the patient.Of last communication, the patient was doing well.The delivery system was discarded, as there was no issue or failure with the edwards device.

Manufacturer Narrative

Additional information through investigational followed up revealed that the ivc filter was a bard retrievable ivc filter g2.The edwards sapien 3 thv is currently under investigation in the united states for pulmonic application.Per the pulmonic ifu, the edwards commander delivery system and accessories are indicated for use as an adjunct to surgery in the management of pediatric and adult patients with the following clinical conditions: dysfunctional rvot conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention, and: regurgitation: = moderate regurgitation, and/or stenosis: mean rvot gradient = 35 mmhg.The ifu cautions that prior to use the patient venous anatomy should be evaluated to prevent the risk of access that would preclude the delivery and deployment of the device.Difficulty tracking the delivery system through the vasculature may be due to anatomical and/or procedural factors, including tortuous vessels, previously implanted stents and/or grafts, wire bias, and kinked ds.In most instances this resolves with routine troubleshooting maneuvers, with minimal risk to the patient.In this case, per report, the difficulty encountered advancing the commander delivery system was attributed to patient factors (interaction with fractured ivc filter).There was no allegation or evidence of a device malfunction or adverse event.Vena cava filters represent an alternative treatment option for patients with contraindications to anticoagulation, or they might serve as adjunctive treatment for continued emboli despite anticoagulation.Initial filters that were developed were permanently placed in the ivc.More recently filters have been developed that are potentially retrievable."retrievable" filters are filters that can be placed in patients at high risk for pe and then removed later when the risk has decreased.Although the filters are designed to be removable, removal can be technically challenging and is not always successful.Manufacturers have different recommendations about how long a filter should stay in, but in general the longer it is left in place, the more difficult it is to retrieve.Filters which are intended for short term placement, but are not removed, are experiencing prolonged exposure to repetitive movement and subsequent metal fatigue.Filter fragmentation might be due to metal fatigue, and therefore its incidence might be directly related to the time that it remains implanted.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; therefore no further actions are required.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.Literature reference: - walsh, j.(2011, february).Safety and effectiveness of inferior vena cava.California technology assessment forum.Https://www.Medscape.Com/viewarticle/744331_2 - nicholson w, nicholson wj, tolerico p, taylor b, solomon s, schryver t, mccullum k, goldberg h, mills j, schuler b, shears l.Prevalence of fracture and fragment embolization of bard retrievable vena cava filters and clinical implications including cardiac perforation and tamponade.Archives of internal medicine.2010 nov 8;170(20):1827-31.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM, 26MM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 7844511
• MDR Text Key: 119669452
• Report Number: 2015691-2018-03668
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/08/2018

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 Expiration Date: 04/18/2020
• Device Model Number: 9600LDS26A
• Device Lot Number: 61354817
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/08/2018
• Initial Date FDA Received: 09/04/2018
• Supplement Dates Manufacturer Received: 09/26/2018; 07/23/2020
• Supplement Dates FDA Received: 10/05/2018; 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1