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  Injury  

Event Description

Through literature review livanova became aware of a (b)(6) male patient supported with protekduo 31 fr.For acute rv dysfunction and respiratory failure 1 day post-heart transplant.His medical history was positive for a rij thrombus 5 years prior which resolved after oral anticoagulation.Following insertion of the protekduo 31 fr.Cannula, he developed symptoms of svc (superior vena cava) syndrome.Venous congestion was reduced using an additional drainage cannula at the patient¿s bedside which led to quick improvement in symptoms.He was weaned from rvad support after 14 days and later discharged after an uncomplicated remaining hospital course.The patient continues to have optimal cardiovascular function nearly 2 years after his heart transplantation.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.

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 milwaukee, wisconsin.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.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

H10: 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 available information and considering that cannula was used for 14 days, a relationship between a device malfunction and the suspected svc syndrome can be excluded.As reported by authors of the article, anatomic variability in svc length as well as cannula size choice are likely underlying contributors to the development of iatrogenic svc syndrome.

Event Description

See initial report.

• 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: 13541349
• MDR Text Key: 285671206
• Report Number: 2531527-2022-00013
• 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): Other