MAUDE Adverse Event Report: AESCULAP AG PAS-PORT PROXIMAL ANASTOMOSIS DEVICE; CARDIO-THORACIC SURGERY

Model Number FG-000001-14

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/29/2020

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 the product pas-port proximal anastomosis device.Specifically, it was reported that the vein could not be removed from the device after successful implantation.The surgery had to be continued with a different surgical approach and partial clamping.An additional medical intervention was necessary.Additional information has been requested but not yet received as of the date of this report.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: the device was available for investigation in a contaminated, deconstructed and heavy soiled condition.The manufacturing documents have been checked and found to be according to specification valid during the time of production.There are no further complaints with this lot at hand.The root cause for the problem is most probably usage related.Without further knowledge about the circumstances, we assume that the tines of the implant were bent during the everting process.The asymmetrical arrangement of the punctures in the diaphragm of the poke- through tool is a sure hint for this assumption.With bent tines a proper anastomosing is not guaranteed.The ifu mentioned further possible points which leading to problems during the operation / anastomosing.According to the ifu the following points must be observed: " do not use conduit if valves or lateral branches are located within 15mm of the end of the conduit to be attached to the implant.Do not ligate lateral branches of the conduit with clips.Do not use conduit if it cannot be pulled through the cartridge by gentle, continous application of force [.] ensure that all nine tines of the anastomosing implant 3b are symmetrical and not bent.[.]".

Manufacturer Narrative

The reportability was reassessed and found to no longer require submission - aesculap is not the legal manufacturer of this device.

• Brand Name: PAS-PORT PROXIMAL ANASTOMOSIS DEVICE
• Type of Device: CARDIO-THORACIC SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10271558
• MDR Text Key: 203103959
• Report Number: 9610612-2020-00294
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K091017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2021
• Device Model Number: FG-000001-14
• Device Catalogue Number: FG-000001-14
• Device Lot Number: 200304F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Date Manufacturer Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention