MAUDE Adverse Event Report: BERLIN HEART GMBH EXCOR®; VENTRICULAR (ASSIST) BYPASS

Model Number	C18A-020
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	05/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The excor apex cannulas for small children (ø 6 mm; l 25 cm, c18a-020), with two different lot numbers (lot no.00138096 and lot no.00141668), were implanted in the patient on (b)(6) 2024 - one as the inflow cannula and one as the outflow cannula.Although both lot numbers were recorded by the site, it was not documented which specific lot number was used for the inflow cannula involved in this incident.The lot number of the affected cannula could not be identified by reviewing the implant records and op notes.Therefore, the event is being reported with both the cannula lot numbers.The event occurred on 2025-05-10, which is (291 days) after the cannulas in question were placed on the patient.The cannulas are no longer on the patient.We have reviewed the production records of the cannula lot no.00138096 and 00141668.The products were produced according to our specification.According to the production records, a total of five cannulas with this lot number were produced.Out of the five cannulas with lot.No.00138096, three were distributed in the us and were used on patients.The remaining two cannulas, which were distributed to south korea, were not used.The details of this lot number are provided in section d4.All five cannulas with lot.No.00141668 were distributed in the us and four of them were used on patients.One cannula was not used.The manufacture date for this lot: 2024-03-27 the expiration date for this lot: 2027-02-28 udi: (b)(4).There are no other complaints associated with either lot number.A detailed investigation report will be provided as soon as it is available.
Event or Problem Description
On 2025-05-11 the site contacted berlin heart inc.(bhi) clinical affairs (ca) to report an inflow cannula breach on the patient who was originally implanted only with excor apex cannula for small children ø 6 mm; l 25 cm.Subsequently, the patient was supported with a excor pediatric vad with excor blood pump pu valves; 10 ml in/out; ø 6 mm.The initial reporter on (b)(6) 2025 described that the patient was sitting up in bed when blood was noticed on her clothing by the bedside staff.During the assessment to find the source of the blood, the patient vomited and began having a seizure.After removing the patient's clothes, a visible "split" was noted in the inflow cannula.Air was noted in the cannula.Both the inflow and outflow cannulas were clamped, and the driving tube was disconnected from the excor ikus driving unit.At this time the patient lost pulses.Despite resuscitation efforts, the patient died.
Additional Manufacturer Narrative
This supplemental report is being submitted in response to the fda letter dated 5/19/2025.The initial mdr report 3004582654-2025-00027 has been submitted on 05/16/2025.
Additional Manufacturer Narrative
Berlin heart commissioned the cardiovascular pathology laboratory, department of veterinary pathobiology, college of veterinary medicine, texas a&m university (tamu), to perform the analysis for the affected cannula (lot no.00141668 or 00138096) along with the excor blood pump (p15p-001; sn (b)(6)).During the examination by the tamu cardiovascular pathology laboratory, only non-destructive visual inspections, photographic recordings, and ct scans were performed.The investigation revealed that the cannula on the inflow side of the blood pump had a velour wrap that was < 5 mm from the tip of the connecting cannula and exhibited a full-thickness breach of the tubing wall.The tear of the tubing appears to have originated from the luminal side of the tubing in line with the cannula, and the continued toward the velour wrapping at an oblique, upstream angle.After the investigation at tamu was completed, the cannula was sent to berlin heart gmbh for investigation.At berlin heart gmbh, the affected product was documented photographically.Based on the evaluation, berlin heart concluded that the reported crack in the cannula occurred possibly due to excessive movements of the patient and/or during routine examination of the blood pump.This could have led to increased internal material stresses in the silicone of the cannula wall and caused the rupture due to tensile stress.Due to the remaining length of the distal end of the cannula without a polyester velour coating, the flexibility of the cannula wall was severely limited, which much has led to increased internal material stresses in the silicone of the cannula wall and most likely resulted in fracture due to external kinking and/or tensile stresses.

• Brand Name: EXCOR®
• Common Device Name: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• Manufacturer (Section G): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• Manufacturer Contact: odell roberts ; 9391 grogan's mill road; suite a-6; the woodlands, TX 77380 ; 2818639712
• MDR Report Key: 22039169
• Report Number: 3004582654-2025-00027
• Device Sequence Number: 21052955
• Product Code: DSQ
• UDI-Device Identifier: 04260090040515
• UDI-Public: (01)04260090040515(17)261031(10)00138096
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P160035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/25/2025

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
• Operator of Device: Health Professional
• Device Model Number: C18A-020
• Device Lot Number: 00138096
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 05/27/2025; 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2023
• 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
• Patient Age: 13 MO
• Patient Sex: Female
• Patient Weight: 5 KG