MAUDE Adverse Event Report: CARDIACASSIST INC. PROTEK DUO VENO-VENOUS CANNULA 31 FR; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 5140-5131

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Obstruction/Occlusion (2422)

Event Type  Death  

Manufacturer Narrative

Patient information was not provided.Serial number is unknown.This information will be provided in a supplemental report if made available.As the serial number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.Cardiacassist inc.Manufactures the protekduo cannula.The incident occurred in (b)(6).A medical assessment of the case was conducted.The reported syndrome is not related to any specific product malfunction and is related to the use of cannula.In addition, this type of event depends on cannula size selected for patient vessel conformation.The syndrome can be solved only by additional medical intervention or by removal of the obstruction.Death of patient is not related to svc syndrome but due to multiorgan failure of the patient.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Through literature review livanova became aware of a (b)(6) female patient supported with the protekduo 31 fr.For rv dysfunction following heartware lvad implant.The patient experienced svc (superior vena cava) syndrome and was determined to have a ¿shorter¿ svc length than compared to other patients in the cohort in exam, which may have contributed to the svc syndrome symptoms.The patient was treated with the addition of a drainage cannula which resulted in rapid resolution of symptoms and she tolerated the rv support well.The remainder of her hospital course was complicated by multisystem organ failure and respiratory failure requiring tracheostomy.There was no improvement in her clinical status after 43 days, and the patient¿s family opted to withdraw support and she subsequently died.The authors believe that anatomic variability in svc length as well as cannula size choice are likely underlying contributors to the development of iatrogenic svc syndrome.Other metrics such as diameter (anteroposterior and lateral) and area did not demonstrate a correlation between size and svc syndrome secondary to obstruction.

Event Description

See initial report.

Manufacturer Narrative

H.10: svc syndrome can be multi-factorial.Due to the right internal jugular vein insertion of the protekduo cannula, svc syndrome may result and it is an inherent risk of the procedure.Lot number of the involved cannula was not stated, thus dhr review could not be performed.Based on gathered information and considering that, as stated in section b.5 of the initial report, patient svc lenght was considered to be "shorter" than compared to other patient, a relationship between a device malfunction and the svc syndrome can be excluded.Thus, the reported svc syndrome is more likely associated to patient vessels conformations.As stated in the initial report, death of patient is not related to svc syndrome but due to multiorgan failure of the patient.

• Brand Name: PROTEK DUO VENO-VENOUS CANNULA 31 FR
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIACASSIST INC.; 620 alpha drive; pittsburgh PA 15238
• Manufacturer (Section G): CARDIACASSIST INC.; 620 alpha drive; pittsburgh PA 15238
• Manufacturer Contact: enrico greco ; 620 alpha drive; pittsburgh, PA 15238
• MDR Report Key: 13541351
• MDR Text Key: 285671424
• Report Number: 2531527-2022-00012
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160257
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/13/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: 5140-5131
• Device Catalogue Number: 5140-5131
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/19/2022
• Initial Date FDA Received: 02/16/2022
• Supplement Dates Manufacturer Received: 03/21/2022
• Supplement Dates FDA Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other