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

Model Number	9600LDS26A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	03/23/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Investigation is underway.
Event or Problem Description
As reported by an edwards field clinical specialist, regarding a 26mm sapien 3 valve in the aortic position via transfemoral approach, the 26mm commander delivery system balloon ruptured while deploying the valve when it was fully inflated with nominal volume, the right coronary sinus also ruptured.The patient was opened to identify the rupture and apply a patch.The 26mm sapien 3 valve was removed and a surgical valve was implanted.The patient did not survive the procedure.
Additional Manufacturer Narrative
Additional information: the facility reported the event under mw5100529.
Event or Problem Description
Additional information: the operational medical records were received and reported after valve deployment, the balloon ruptured.An echocardiogram revealed a pericardial effusion.The patient was converted to open procedure to alleviate the cardiac tamponade caused by an aortic annular rupture.The s3 was explanted, a pericardial patch was placed, and a surgical aortic valve was implanted.The surgery; however, was further complicated by events occurring during the sternotomy along with unexpected vascular injuries.While still in the surgery suite, the patients status deteriorated and was pronounced dead.
Additional Manufacturer Narrative
The device was not returned for evaluation.Patient imagery was provided for review and showed calcification present in the patient annulus and leaflets.A device history review (dhr) was performed and did not reveal any manufacturing nonconformance's issues that would have contributed to the complaint.A technical summary written by edwards infectiveness is applicable for this complaint thus an engineering evaluation is not required.Since no edwards defect was identified no corrective or preventative action is required.Complaint trending is conducted.The risk of annular rupture and associated harms has been reduced as low as possible through design and manufacturing processes.Edwards has provided guidelines and instruction to the physicians in the ifu and training materials and refer training on how to deploy thv users are informed of the residual risk associated with annular rupture.Therefore the review of risk management files is compete and no further action is required.The reported event was unable to be confirmed neither applicable imagery nor device was returned.As the complaint device was not returned engineering was unable to perform visual functional or dimensional analysis.Therefore no manufacturing nonconformance's were able to be identified.A detailed root cause analysis for similar complaint has been summarized in a technical summary written by edwards lifesciences.The technical summary provides the details why balloons are subject to increase risk of burst in a calcified annulus.As reported the 26mm commander 26mm commander delivery system balloon ruptured while deploying the valve when it was fully inflated with nominal volume it was noted that there was calcification present in the patient native annulus it is possible that calcification present in the landing zone could have weakened the balloon material contributing the burst the presence of calcification can create a challenging anatomy for balloon inflation while the balloons are sufficiently designed and tested for rated burst pressures well above their inflation pressure calcified nodules can compromise the structure of the balloon wall via following mechanisms such as puncture local overstretching open cell impingement or stress concentration the technical summary also outlines the extensive manufacturing mitigation's in place to prevent this type of malfunction visual and dimensional inspections leak testing and functional balloon burst testing that occurs with every manufactured lot these inspections and testing support that it is unlikely that a defect present in manufacturing contributed to the complaint it should be noted that these mitigation's are still in place however a definite root cause was unable to be determined available information therefore suggests that patient factors calcification likely contributed to the complaint event in addition the annular rupture that occurred was likely due to the balloon burst from the patients calefied annulus.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11679048
• Report Number: 2015691-2021-02497
• Device Sequence Number: 3570709
• Product Code: NPT
• UDI-Device Identifier: 00690103193954
• UDI-Public: (01)00690103193954(17)230107(10)63582959
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P140031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/22/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/07/2023
• Device Model Number: 9600LDS26A
• Device Catalogue Number: 9600LDS26A
• Device Lot Number: 63582959
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 04/30/2021; 05/06/2021; 05/21/2021
• Initial Report FDA Received Date: 04/16/2021
• Supplement Report FDA Received Date: 04/30/2021; 05/07/2021; 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention