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

Catalog Number 5140-4629

Device Problem Obstruction of Flow (2423)

Patient Problems Low Blood Pressure/ Hypotension (1914); Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

Patient identifier, weight and ethnicity were not provided.Date of event is unknown.Lot number was not provided, so udi and expiration date are unknown.As lot number was not provided, manufacturing date could not be determined.Livanova manufactures the protekduo cannula.The incident occurred in birmingham, united kingdom.During follow-up communication with a medical affairs expert, it was revealed that if the protekduo is not ideally positioned, it can occupy the superior vena cava, creating suction and collapse of the vessel around the cannula, and restrict venous return to the right atrium.This is well documented in the literature beyond the use of the protekduo, with smaller bore devices or anatomical abnormalities.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.

Event Description

During a literature review, livanova identified an article (s.D.Minns, et.Al, april 2021) evaluating dual lumen cannulas used for right heart failure following a heart transplant.The article described a protekduo 29fr cannula which was inserted to provide rvad support on a female patient.Following placement, the patient experienced facial swelling, hypotension unresponsive to fluids and increasing support requirements.An echocardiogram showed normal right ventricular size with no effusion and a chest radiograph confirmed that the protekduo cannula was appropriately positioned.Superior vena cava (svc) obstruction was subsequently demonstrated on venogram, with svc pressures of 36mmhg with no pulsivity.The protekduo was exchanged for a dual cannula configuration with a 25fr multistage cannula draining via the femoral vein and a 19fr single-stage return to the pulmonary artery.Pressure measurement continued showing a persistent gradient across the svc.A 17fr cannula was inserted for drainage and the patient was returned to theatre for an svc repair and was weaned off support.The article indicated that the patient is moving forward with recovery.

Manufacturer Narrative

Multiple efforts were made to contact authors of the article, however these attempts were unsuccessful and no response has been received at this time.Livanova clinical and med affairs made an effort to get contact information for the 3 authors without success.As there were no email addresses or other contact information listed in the literature, the hospital phone number was the only method by which livanova could attempt to make contact.Livanova was able to get a hold of hospital staff at university hospital birmingham, however they stated that the main author was not listed as employed.Another author was listed as an employee but all attempts to reach his voicemail were unsuccessful.The remaining author also could not be located.As the authors of the article could not be reached and the involved device was not made available for investigation at livanova, an exact root cause could not be determined.However, during follow-up communication with a medical affairs expert, it was revealed that if the protekduo is not ideally positioned, it can occupy the superior vena cava, creating suction and collapse of the vessel around the cannula, and restrict venous return to the right atrium.This is well documented in the literature beyond the use of the protekduo, with smaller bore devices or anatomical abnormalities.A dhr review could not be performed as no lot number was made available.The most likely cause of the event was that the protekduo cannula was a non-ideal position of the device, creating suction and causing the vessel around the cannula to restrict blood flow.However, as the reported event and root cause could not be confirmed, no specific action is currently deemed necessary.If any additional information relevant to the reported event is received, it will be provided in a supplemental 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: ryan coyle ; 620 alpha drive; pittsburgh, PA 15238
• MDR Report Key: 15797444
• MDR Text Key: 303641114
• Report Number: 2531527-2022-00053
• 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
• Type of Report: Initial,Followup
• Report Date: 02/16/2023

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 Catalogue Number: 5140-4629
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/27/2022
• Initial Date FDA Received: 11/15/2022
• Supplement Dates Manufacturer Received: 01/24/2023
• Supplement Dates FDA Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female