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

Model Number FG-000001

Device Problem Difficult or Delayed Separation (4044)

Patient Problem Blood Loss (2597)

Event Date 01/15/2020

Event Type  Injury  

Manufacturer Narrative

Per the instructions for use, the user is instructed to grasp the conduit close to the implant with forceps while the device is being removed to avoid placing tension on the anastomosis.The user is also instructed to wet the venous conduit and the device by flushing with non-cellular physiologic solution if the venous conduit has become dried to the inside of the device.

Event Description

The patient was undergoing an off-pump coronary artery bypass.Following deployment of the implant to the aorta, the surgeon tried to remove the delivery device but found it was difficult to remove.The surgeon "strongly pulled the device," which caused separation of the anatomosis between the aorta and the saphenous vein graft (svg) which had been formed by use of the implant.The surgeon then completed the bypass by suturing the same svg at an alternate aortic location.There were no reported patient complications and the procedure was completed.

• 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: 9781250
• MDR Text Key: 189444940
• Report Number: 3004114958-2020-00001
• 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: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2021
• Device Model Number: FG-000001
• Device Catalogue Number: FG-000001
• Device Lot Number: 190614E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2019
• 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): Required Intervention