MAUDE Adverse Event Report: AESDEX, LLC CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM; CLIP

Model Number FG-000001

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Left Ventricular Dysfunction (1947); Right Ventricular Dysfunction (2054); Great Vessel Perforation (2152); Shock, Postoperative (2266); Blood Loss (2597); Multiple Organ Failure (3261)

Event Date 03/17/2020

Event Type  Death  

Event Description

The patient underwent an off-pump coronary artery bypass (opcab) due to triple vessel coronary artery disease.As part of the procedure, the surgeon used the pas-port proximal anastomosis system (clip) with a saphenous vein graft to complete the proximal anastomosis of a coronary artery bypass.Following deployment of the clip, the surgeon noted the clip had penetrated through the anterior wall of the aorta where it should have been affixed, but rather was affixed to the posterior wall of the aorta.Bleeding was seen at the posterior wall of the ascending aorta.The surgical staff manually stopped the bleeding and placed the patient on cardiopulmonary bypass to remove the clip, repair the site of bleeding, and complete the coronary artery bypass surgery.Subsequently, bleeding was again noted from the posterior wall of the aorta and required further repair.The patient's condition became unstable requiring an intra-aortic balloon pump and percutaneous cardiopulmonary support prior to completion of the surgery.On (b)(6) 2020, the patient underwent further chest surgery for increased bleeding from a site associated with use of a temporary pacemaker.No bleeding was noted at the previously repaired aorta.However, the patient's condition deteriorated and the patient subsequently died due to multi-organ failure.

• Brand Name: CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM
• Type of Device: CLIP
• Manufacturer (Section D): AESDEX, LLC; 2464 embarcadero way; palo alto, ca
• Manufacturer (Section G): AESCULAP AG; am aesculap-platz; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: todd pope ; 2464 embarcadero way; palo alto, ca ; 3317108
• MDR Report Key: 10063511
• MDR Text Key: 191222696
• Report Number: 3004114958-2020-00002
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 11814900000017
• UDI-Public: 11814900000017
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K091017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2021
• Device Model Number: FG-000001
• Device Catalogue Number: FG-000001
• Device Lot Number: 190614D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2019
• 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): Death; Required Intervention
• Patient Age: 68 YR