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

Model Number	FG-000001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Death (1802); Left Ventricular Dysfunction (1947); Right Ventricular Dysfunction (2054); Great Vessel Perforation (2152); Shock, Postoperative (2266); Blood Loss (2597); Multiple Organ Dysfunction Syndrome (3261)
Date of Event	03/17/2020
Type of Reportable Event	Death
Event or Problem 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
• Common Device Name: CLIP
• Manufacturer (Section D): AESDEX, LLC; 2464 embarcadero way; palo alto, ca
• MDR Report Key: 10063511
• Report Number: 3004114958-2020-00002
• Device Sequence Number: 17044052
• Product Code: FZP
• UDI-Device Identifier: 11814900000017
• UDI-Public: 11814900000017
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K091017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 05/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 68 YR