MAUDE Adverse Event Report: BERLIN HEART GMBH EXCOR APEX CANNULA FOR CHILDREN; VENTRICULAR ASSIST DEVICE

Model Number	C22A-004
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	12/19/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
The excor cannula lot 00060726, was in use by the patient from (b)(6) 2018 until (b)(6) 2021 (1108 days).We have reviewed the production records of the excor cannula lot 00060726.This cannula was produced according to our specification.The investigation is still ongoing and a detailed investigation report will be provided as soon as it is available.
Event or Problem Description
We were informed by the distributor on (b)(6) 2021 about a breach in the inflow cannula of a patient supported with the excor pediatric in the lvad configuration.The clinic reported the breach was found in the cannula in the area of the blood pump connector.Air was introduced into the cannula at the site of the breach resulting in an air embolism to the patient.The patient, who had been supported with the excor pediatric for 1108 days died as a result of this event.
Additional Manufacturer Narrative
During initial visual examination of the returned products a defect at end of the inflow cannula transverse to the flow direction was detected.The breach was located below the edge of the connector, in the section between connector and outer velour of the cannula.Ct-scan was done for both cannula ends (inflow & outflow).The results of the ct-scan confirmed the defect at the end of the inflow cannula.The geometry and the structure of the breach in the cannula wall of the inflow cannula leads to the assumption that a high external force on the cannula occurred.Further detailed investigation showed multiple traces on the inner surface of both cannulas due to strong overload in the section between connector and outer velour of the cannulas.Additionally, it can be noted, the cannulas, especially the inflow cannula, might have been stretched and kinked several times in the same direction caused by moving the pump upright from the patient's body during excessive movement from the patient.Due to the remaining length of the distal end of the cannula without polyester velour covering was very small, the flexibility of the cannula wall was severely restricted.This could have led to increased internal material stresses in the silicone of the cannula wall and may have contributed to the fracture of the cannula wall due to external kinking and/or tensile stress.The combination of the occurrence of high external forces on the cannula over multiple times and the limited distance between connector and velour, can be assumed as cause for the breach in the cannula wall.

• Brand Name: EXCOR APEX CANNULA FOR CHILDREN
• Common Device Name: VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, deu 12247 ; GM 12247
• Manufacturer (Section G): BERLIN HEART GMBH; wiesenweg 10; berlin, deu 12247 ; GM 12247
• Manufacturer Contact: dudley rajapaksa ; 9391 grogan's mill road; suite a-6; the woodlands, TX 77380 ; 2818639706
• MDR Report Key: 13236051
• Report Number: 3004582654-2022-00006
• Device Sequence Number: 4405443
• Product Code: DSQ
• UDI-Device Identifier: 04260090040492
• UDI-Public: 04260090040492
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P160035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2022

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: 11/30/2019
• Device Model Number: C22A-004
• Device Catalogue Number: C22A-004
• Device Lot Number: 00060726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2021
• Supplement Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/29/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 11 YR
• Patient Sex: Female