MAUDE Adverse Event Report: AESCULAP AG PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM; ANASTOMOSIS DEVICES

Model Number FC700SU

Device Problem Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with fc700su - pas-port proximal anastomosis system.According to the complaint description, the anastomosis could not be performed during surgery.The pas-port only turns once and then blocks.The hole has been punctured in the aorta, but it did not go any further.The aorta was clamped, the graft was removed from the pas-port (destroying the pas-port in the process) and the anastomosis was sutured by hand.An additional medical intervention was necessary.Additional information was not provided.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: visual investigation: the device was not returned for investigation.In similar cases like the present one, the investigation did not reveal any abnormalities on the pas-port device and the individual parts itself.No damages could be found which may explain the failure pattern.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that 3 similar complaints have been filed against products from this batch number.The review of risk assessment revealed the overall risk level (4(5) severity x 2(5) probability of occurrence).Conclusion and measures / preventive measures: a significant number of complaints was reported describing issues during the deployment phase of the pas-port proximal anastomosis system.The pas-port system is designed to create an anastomosis between a large target vessel, such as the aorta, and a conduit, such as a venous conduit.The deployment phase is defined as the steps after loading of the venous graft until the proximal anastomosis is successfully completed.The market feedback indicates problems at different steps during the deployment phase: either at the aortotomy step i.E.Aortotomy only or incomplete or unsuccessful, or problems with the implant formation or anastomosis were stated, i.E.The implant did not deploy successfully, was dislodged from the aorta or had to be removed because of uncontrolled bleeding from the implant site or the anastomosis was incomplete.The root cause could not be determined.A systematic and cross-batch problem was identified.Based on the risk scenario aesculap ag decided to recall the affected products.

• Brand Name: PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM
• Type of Device: ANASTOMOSIS DEVICES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11648927
• MDR Text Key: 251238572
• Report Number: 9610612-2021-00294
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K202124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/28/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2022
• Device Model Number: FC700SU
• Device Catalogue Number: FC700SU
• Device Lot Number: 52648699
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/16/2021
• Initial Date FDA Received: 04/12/2021
• Supplement Dates Manufacturer Received: 06/28/2021
• Supplement Dates FDA Received: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention