MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. CARBOSEAL VALSALVA ASCENDING AORTIC PROSTHESIS

Model Number CP-023

Device Problems Delivery System Failure (2905); Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/06/2016

Event Type  Death  

Manufacturer Narrative

It is not clear the correlation of the delivery issue with the reported patient's status.The reported issue is related to the removal of the handle once completed the suturing of the prosthesis.

Event Description

As per our distributor, the event occurred last (b)(6) at: hospital (b)(6), with the physician team of (b)(6), who has a large experience with the procedure and products sorin.The case was reported as follows: on saturday (b)(6) 2016, during surgery after proximal suture the valve, the surgeon keeping fixed (without rotating) the lever of the holder, pressed the release button according to the product manual, but the holder did not unfasten the prosthesis.Because several attempts to release the holder in accordance with the product manual instructions, the team made an attempt to release by surgical instrumentation tools for removal holder, detaching the piece mechanically, which came out with one of the valve leaflets.Besides, according to the distributor the surgery has delayed 30 minutes and a new competitor's product has been used.No damaged related to the product occurred to the patient according to the physician team.In addition and for a second time we were informed that the patient arrived at the hospital on friday, in emergency character.He was immediately attended and by exams, it was found that there was an aortic aneurysm.In emergency character, the aortic dissection surgery was performed.After sorin's item implantation procedure, it was not possible to disconnect the valve, forcing the doctor to explant it.This whole process took 30 minutes.The physician then chose to use a new competitor's model in the patient, and everything went in a satisfactory manner within the recommended limits of cp procedure.However, when the final suture was concluded the patient had lost his vital signs and it was not possible to recover him.It is also reported that the patient had received hard drugs such as adrenaline and noradrenaline, and this may have affected the clinical picture.Medical staff have not co-related to failure of the product to the death of the patient, considering the doctor's experience working with sorin products as well as product quality.Specifically, during the explantation procedure, the patient was alive and his vital conditions monitored.During the implantation process of competitor's device, the patient remained alive without changes in his vital condition until almost surgery ends, when he missed the signs and came to death.

Manufacturer Narrative

The manufacturing and material records for this carbomedics carboseal valsalva were pulled and reviewed by quality control of livanova.The results confirmed that this ascending aortic prosthesis sn (b)(4) satisfied all material, visual and performance standards required for a size 23 carbomedics carboseal valsalva at the time of manufacture and release.Upon receipt of the device, a visual inspection was performed.The carboseal valsalva was received without one leaflet, and with the handle loose in the carton box and the fragments of the leaflet and handle's extremity fixed with adhesive tape inside the original blister.The orifice of the valve component showed damaged area corresponding to the hinge cavity of the broken leaflet, while no macroscopic mark of damage were observed on the opposite hinge nor on the inflow or outflow surfaces of the leaflet still in position.The handle was received with marks attributable to contact with tools, and both extremities detached/missing.Nevertheless, the releasing mechanism was still free to move into the releasing position.A simulation of the prosthesis release was performed using the returned prosthesis and a demonstration handle.No anomalies were observed during the operation, despite the heavily damaged receiving condition.The returned holder, although damaged, was free to move the tilting component in the releasing position, and no sticking was identified.The breakage of the "u" shaped housing of the handle cursor was examined microscopically, and found to be consistent with a relative rotation between the cursor and the handle, causing bending of a portion of the housing.The breakage of the "u" shaped housing.Despite the returned system being heavily damaged, the product analysis performed revealed no indication of pre-existing failure.The root cause of the event could be attributed to a concomitance of factors occuring after initial difficulties releasing the handle resulting from the entrapment of foreign material in the moving elements (eg.Tangled sutures).Based on the investigation performed, the event was deemed attributable to mishandling or misuse which likely caused or contributed to the deterioration of the overall scenario.The manufacturer acknowledges the late reporting of this supplemental information.

• Brand Name: CARBOSEAL VALSALVA ASCENDING AORTIC PROSTHESIS
• Type of Device: CARBOSEAL VALSALVA
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; via crescentino sn; saluggia, vc 13040 ; IT 13040
• Manufacturer (Section G): SORIN GROUP ITALIA S.R.L.; via crescentino sn; saluggia, vc
• Manufacturer Contact: giovanni bergamasco ; via crescentino sn; saluggia, vc ; 9161487034
• MDR Report Key: 5931697
• MDR Text Key: 54021222
• Report Number: 3005687633-2016-00015
• Device Sequence Number: 1
• Product Code: DYE
• UDI-Device Identifier: 08022057013545
• UDI-Public: (01)08022057013545(240)CP-023(17)180130
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P900060/S024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2018
• Device Model Number: CP-023
• Device Catalogue Number: CP-023
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 66 YR