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

Model Number UNKNOWN

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 with a history of durable vad explant for recovery presenting with lvef of 10% and rv dysfunction.After implantation of lvad and protekduo for rv support, the patient experienced symptoms of svc (superior vena cava) syndrome.Over the next 3 hours, the symptoms improved, the rvad support was then removed with resolution of svc syndrome symptoms shortly after removal.The patient had a dual-chamber icd in place during rvad placement and removal, which might have contributed to reduced svc distensibility.The authors concluded that patients with signs of svc syndrome, including facial and chest edema, dyspnea and cough, and nonpulsatile distended neck veins, experienced improvement following either device explantation or removal of the accompanying central venous catheter within the left internal jugular and subclavian venous system.The authors hypothesize that consideration needs to be given to multiple etiologies for svc syndrome and appropriate rv support and early recognition of svc syndrome are needed for preventing venous 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 (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.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

H.10: as stated in the initial report the reported event is not related to any cannula malfunction.Svc syndrome can be multi-factorial and is an inherent risk of the procedure related to the use of a cannula.In this specific case, as stated in b.5 section of the initial report, the patient had a dual-chamber icd in place during rvad placement and removal, which might have contributed to reduced svc distensibility.

Event Description

See initial report.

• Brand Name: PROTEK DUO VENO-VENOUS CANNULA
• 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: 13541350
• MDR Text Key: 285733576
• Report Number: 2531527-2022-00010
• 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: UNKNOWN
• Device Catalogue Number: UNKNOWN
• 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: 03/19/2022
• Supplement Dates FDA Received: 04/15/2022
• 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