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

Model Number COMMANDER DELIVERY SYSTEM UNKNOWN

Device Problems Burst Container or Vessel (1074); Degraded (1153); Fracture (1260); Difficult to Remove (1528)

Patient Problems Stenosis (2263); Injury (2348)

Event Date 12/01/2014

Event Type  Injury  

Manufacturer Narrative

In this case, the exact delivery system model number is not available.Therefore, this report will reflect an unknown transfemoral delivery system.The possible pma numbers associated with an edwards delivery system are listed below; this report will remain blank.P110021- retroflex 3 delivery system; p130009 ¿ novaflex+ delivery system; p140031- edwards commander delivery system.The date of the event(s) is unknown.According to the article the date range for this event(s) is from december 2014 and may 2019. for this reason, the first day of the range was used as the occurrence date.  per the instructions for use (ifu), balloon rupture is a potential risk of the tavr procedure.Transcatheter delivery balloon burst complaints have been previously investigated by edwards and documented in a technical summary written by edwards lifesciences.  a detailed root cause analysis revealed that it is very unlikely that a product defect contributes to this type of event.There are extensive manufacturing inspections in place to prevent this type of malfunction (visual and dimensional inspections, leak testing, and functional balloon burst testing performed to every manufactured lot).The thv delivery system balloons are subject to increased risk of burst due to contact with a highly calcified annulus.The ¿annulus¿ may refer to a patient¿s native annulus (in the aortic, pulmonic, mitral, or tricuspid position), or a previously implanted thv, surgical valve, or ring in the aortic, pulmonic, mitral or tricuspid position.Analysis revealed that these types of ruptures are typically caused by puncture from calcium on the annulus when the inflated delivery system balloon comes in contact with the calcification at full inflation/deployment.In this case, investigation results are inconclusive, as relative patient and procedural information was not provided, so the exact cause of the balloon burst is unknown.However, it could be related to the mechanisms described above.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 on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required at this time.  article reference: 1: costa g, de backer o, pilgrim t, kasel m, redwood s, aminian a, lanz j, michel j, patterson t, windecker s, prendergast b, greenbaum ab, søndergaard l.Feasibility and safety of transcaval transcatheter aortic valve implantation: a multicentre european registry.Eurointervention.2020 feb 7;15(15):e1319-e1324.Doi: 10.4244/eij-d-19-00797.Pubmed pmid: 31659987.

Event Description

As reviewed by our affiliates for (b)(6) of the medical article: " initial european experience with transcaval transcatheter aortic valve implantation".Corresponding author ole de backer, the following events were identified: between december 2014 and may 2019, fifty patients with severe native aortic valve stenosis or a degenerated surgical aortic bioprosthesis underwent tavi by transcaval access in five european tavi centers.Half of the patients (52%) were treated with a balloon-expandable transcatheter aortic valve (sapien 3, n=26).In one patient, the regular closure device could not be used as the sapien-implantation balloon had ruptured and could not be retrieved into the sheath, forcing removal of the entire system including the introducer sheath ¿ this case required implantation of a covered stent over the puncture site, which was successful and avoided a major vascular complication.

Manufacturer Narrative

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

• Brand Name: UNKNOWN EDWARDS DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9857489
• MDR Text Key: 189886719
• Report Number: 2015691-2020-11037
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 02/25/2020

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: COMMANDER DELIVERY SYSTEM UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/25/2020
• Initial Date FDA Received: 03/19/2020
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1