MAUDE Adverse Event Report: DEXTERA SURGICAL INC. CARDICA® PAS-PORT® PROXIMAL ANASTOMOSIS SYSTEM; IMPLANTABLE CLIP

Model Number	FG-000001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	11/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Only the implant was returned to the manufacturer for evaluation with the delivery system having been discarded at the reporting hospital.Thus, the investigation and inspection of the implant by the manufacturer was conducted following insertion and removal of the implant from the patient.The implant contains a series of radial tines that provide tissue opposition between the graph and aorta to create the anastomosis.Physical examination of the implant demonstrated that all tines were intact and appeared to be formed completely with some distortion of two outer tines.It is unclear if the distortion occurred at the time of deployment or removal of the implant from the aorta and the graft.Since the delivery system was discarded at the reporting hospital, functional testing of the device was unable to be performed.Corrected data: corrected mfr report #.Incomplete device returned.
Event or Problem Description
It was reported that during an off-pump coronary artery bypass graft (cabg) procedure, a pas-port device was used.The surgeon deployed the implant and the anastomosis was successfully created.Following implantation, two severe leakages were noted at the implant site.The surgeon clamped the aorta and removed the implant.The surgical procedure was converted to an on-pump cabg.An enclose ii proximal anastomosis assist device (vitalitec international, inc.) was later used.The surgery was successfully completed with no reported patient complications.

• Brand Name: CARDICA® PAS-PORT® PROXIMAL ANASTOMOSIS SYSTEM
• Common Device Name: IMPLANTABLE CLIP
• Manufacturer (Section D): DEXTERA SURGICAL INC.; 900 saginaw dr.; redwood city CA 94063
• MDR Report Key: 8356450
• Report Number: 3004114958-2016-00005
• Device Sequence Number: 2287535
• Product Code: FZP
• UDI-Device Identifier: 11814900000017
• UDI-Public: (01)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): 12/16/2016

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: 02/01/2018
• Device Model Number: FG-000001
• Device Catalogue Number: FG-000001
• Device Lot Number: 160524B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2016
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2016
• Initial Report FDA Received Date: 02/20/2019
• 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