MAUDE Adverse Event Report: CARDIAC ASSIST, INC. TANDEMHEART VENO-VENOUS CANNULA (PROTEKDUO)

Model Number 5140-4629

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Vascular Dissection (3160)

Event Date 12/08/2014

Event Type  Injury  

Event Description

A (b)(6) male with a history of biventricular failure was implanted with a heartware lvad, but was unable to maintain flow due to cardiopulmonary failure involving the right ventricle.The protek duo was placed in the right internal jugular vein using a 0.035 lunderquist guidewire under transesophageal echocardiographic and fluoroscopic guidance.Position was verified by anesthesia.Pt was weaned from bypass and chest was being closed when the pt's blood pressure began to drop.Bleeding was noted, the chest was reopened, and he was placed back on bypass.Dr (b)(6) noted the pt had a friable pulmonary artery which had dissected near the right ventricular outflow tract.Dr (b)(6) also noted that protek duo cannula migration most likely occurred during weaning from bypass when the ventricles filled to capacity and were conducting/contracting on their own.The pulmonary artery was surgically repaired, the proteck duo was removed, and ecmo cannulas were implanted in order to continue cardiopulmonary support.The pt, at last reported 14 days following the procedure, had been successfully weaned off of temporary support and was in stable condition.

• Brand Name: TANDEMHEART VENO-VENOUS CANNULA (PROTEKDUO)
• Type of Device: VENO-VENOUS CANNULA
• Manufacturer (Section D): CARDIAC ASSIST, INC.; pittsburgh PA
• Manufacturer Contact: greg johnson ; 240 alpha dr.; pittsburgh, PA 15238 ; 4129637770
• MDR Report Key: 4404498
• MDR Text Key: 17263180
• Report Number: 2531527-2014-00006
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K140999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2014

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 Expiration Date: 08/31/2015
• Device Model Number: 5140-4629
• Device Catalogue Number: 5140-4629
• Device Lot Number: AM047238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2014
• Initial Date FDA Received: 01/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• 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
• Treatment: HEARTWARE LVAD
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 80