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

Model Number 5140-4629

Device Problem Partial Blockage (1065)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 07/07/2021

Event Type  Injury  

Event Description

Through literature review livanova became aware of a (b)(6)-year old patient that experienced an internal jugular vein thrombosis during support with a protekduo cannula which was resolved after administration of oral anticoagulation.The patient was supported with the protekduo cannula for 4 days (the protekduo cannula was connected to a centrimag-abbott blood pump) and was then weaned off of protekduo support and successfully discharged from the hospital, without clinical or echocardiographic signs of rv dysfunction.

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).Within the article the exact date of the event was not specified.The date of the article is 07-jul-2021.Within the article it is stated that during protekduo support, continuous intravenous ufh (unfractioned heparin) was administered to reach an activated partial thromboplastin time of 50-60 seconds.A medical evaluation of the reported event was performed.The outcome was that the ptt (partial thromboplastin time) during operation was low and that a ptt of 65 to 80 seconds would have decreased the risk of clotting.Through follow up communication with the customer, pictures of the cannula used during support were shared.Analysis of provided pictures confirmed presence of clot.Through further follow up communication with the customer, it was learned that the act value after insertion of the cannula was < 340 seconds.Reportedly, the patient was assisted for a total of 10 days maintaining a ptt value on average around 45-50 (extremes between 40 and 55).In addition, it was reported by the customer that when the reported event occurred, only ptt, fibrinogen and platelet count were monitored while the act (activated clotting time) was not monitored.As per device instruction for use the user is required to maintain patient act of approximately 180 to 220 seconds during use of the protekduo cannula and the lack in monitoring act may have resulted in an inadequate anticoagulation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

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).Within the article the exact date of the event was not specified.The date of the article is 07-jul-2021.Within the article it is stated that during protekduo support, continuous intravenous ufh (unfractioned heparin) was administered to reach an activated partial thromboplastin time of 50-60 seconds.A medical evaluation of the reported event was performed.The outcome was that the ptt (partial thromboplastin time) during operation was low and that a ptt of 65 to 80 seconds would have decreased the risk of clotting.Through follow up communication with the customer, pictures of the cannula used during support were shared.Analysis of provided pictures confirmed presence of clot.Through further follow up communication with the customer, it was learned that the act value after insertion of the cannula was < 340 seconds.Reportedly, the patient was assisted for a total of 10 days maintaining a ptt value on average around 45-50 (extremes between 40 and 55).In addition, it was reported by the customer that when the reported event occurred, only ptt, fibrinogen and platelet count were monitored while the act (activated clotting time) was not monitored.As per device instruction for use the user is required to maintain patient act of approximately 180 to 220 seconds during use of the protekduo cannula and the lack in monitoring act may have resulted in an inadequate anticoagulation.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) year old patient that experienced an internal jugular vein thrombosis during support with a protekduo cannula which was resolved after administration of oral anticoagulation.The patient was supported with the protekduo cannula for 4 days (the protekduo cannula was connected to a centrimag-abbott blood pump) and was then weaned off of protekduo support and successfully discharged from the hospital, without clinical or echocardiographic signs of rv dysfunction.

Event Description

See initial report.

Manufacturer Narrative

H10: dhr review could not be performed since lot number of cannula was not provided.Based on the available information, the reported event is unlikely to be related to a specific device malfunction and is more likely related to patient condition and/or to the specific anticoagulation therapy applied.

• 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: 13535131
• MDR Text Key: 285621646
• Report Number: 2531527-2022-00006
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 01/18/2022

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: 5140-4629
• Device Catalogue Number: 5140-4629
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2022
• Initial Date FDA Received: 02/15/2022
• Supplement Dates Manufacturer Received: 03/17/2022
• Supplement Dates FDA Received: 04/14/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR