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 Code	Failure to Anastomose (1028)
Date of Event	01/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An incomplete device was returned with damage to the delivery system noted upon return, which was previously not reported.The user indicated there were no issues with the clip prior to use or any issues during the delivery/anastomosis process.Given the condition of the returned device, a complete investigation was not possible and a conclusion regarding the cause of the event cannot be determined.
Event or Problem Description
The device's clip was used to create the proximal anastomosis of a bypass graft during open cardiac bypass surgery.Approximately two hours after creating the anastomosis and prior to completion of the surgery, the graft dislodged from the aorta.While using a pump-oxygenator, the surgeon removed the clip from the graft and sutured the graft to another location.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 94303
• MDR Report Key: 8341327
• Report Number: 3004114958-2019-00001
• Device Sequence Number: 14016452
• 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
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/14/2019

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: 11/09/2019
• Device Model Number: FG-000001
• Device Catalogue Number: FG-000001
• Device Lot Number: 180301B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 02/14/2019
• 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