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

Model Number	FG-000001
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	01/15/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: CLIP
• Manufacturer (Section D): AESDEX, LLC; 2464 embarcadero way; palo alto, ca
• MDR Report Key: 9781250
• Report Number: 3004114958-2020-00001
• Device Sequence Number: 2649853
• 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): 03/03/2020

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 03/03/2020
• 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: Required Intervention