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	Loss of consciousness (2418)
Date of Event	06/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned for investigation, but neither the clip nor any accessories were returned with the device.Based on the visual and functional assessments of the returned device, there were no issues found with the device and the device functioned as intended.Therefore a root cause or causes of the reported event cannot be determined.
Event or Problem Description
The patient was undergoing an on-pump beating heart coronary artery bypass graft (cabg) procedure.The surgeon elected to use the pas-port proximal anastomosis system to anastomose the proximal portion of the saphenous vein graft (svg) to the aorta.As reported, the condition of the aorta was "not good".After deploying the pas-port clip, the surgeon lifted the deployment portion of the device while holding the clip/svg with forceps.The clip dislodged from the anastomosis site, which required that the surgeon repair the aortic anastomosis site.The surgeon completed the cabg procedure.Following surgery, it was reported that the patient was initially unconscious.The cause was not reported but a cerebral infarction was ruled out.The patient subsequently regained consciousness and improved such that the patient is tolerating food consumption.

• 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: 8786235
• Report Number: 3004114958-2019-00002
• Device Sequence Number: 16643978
• 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): 07/12/2019

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: 06/21/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 07/12/2019
• 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: Other; Required Intervention
• Patient Age: 73 YR