MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. CARBOSEAL VALSALVA ASCENDING AORTIC PROSTHESIS; HEART VALVE, MECHANICAL

Model Number CP-027

Device Problems Leak/Splash (1354); Defective Component (2292)

Patient Problem Connective Tissue Disease (1786)

Event Date 10/20/2017

Event Type  Injury  

Manufacturer Narrative

A complete manufacturing and material records review for the device has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.Device available but not yet received.

Event Description

(b)(6) 2017, a carboseal valsalva 27 mm valve graft was implanted for a bentall procedure.After all anastomoses were complete, it was found that the graft was leaking at the juncture between the valve and the graft.The physician placed a stitch in the area that the graft was leaking, but the leaking continued.After inspecting the graft, the physician believed the device to be defective and removed the product.A 30 mm tube graft and 23 mm top hat mechanical aortic valve were then implanted.The physician reported that, after removing the carboseal, a simple tube graft was sewn at the annular level and the top hat was sewn into the graft above the anastomosis.This was done to ensure the anastomosis was secure in the patient's fragile tissue.The patient was a marfan's patient with friable tissue.The surgery was delayed by 4 hours as a result of the event.

Manufacturer Narrative

The device was received for analysis on (b)(6) 2017.On (b)(6) 2017, a gross examination was conducted.The returned valve prosthesis was received with visible traces of collagen on the graft and also on the leaflets.The leaflets of the mechanical valve appeared to open/close normally.Two holes were observed on the graft, and evidence of the suturing stitches on the outflow ring were detected.(b)(4).

Manufacturer Narrative

Visual inspection of the returned valve confirmed the absence of non conformities and pre-existing defects.Two holes were observed on the graft surface, indicating the location of the anastamoses made during the implant procedure.One of these holes was formed by cutting the graft to release the anastamosis.Due to the size of the hole created during the explant procedure, it was not possible to conduct a permeability test, and the integrity of the graft could not be confirmed.Damage to the graft observed by microscopic evaluation suggests that the graft may have been punctured by the suturing needle during implant.However, this damage may also have been created during an attempt to repair the reported leakage.Given that a permeability test could not be performed, the integrity of the conduit and valve could not be confirmed, and it is was not possible to identify the root cause of the event.It is possible that damage to the graft occurred during the implant procedure; however, the possibility that this damage occurred during attempted repair of the reported leak cannot be excluded.It should also be noted that blood leakage through or around the cuff of valved conduits is a phenomenon that is occasionally observed during the implant of conduits made by most, if not all, manufacturers.Given this, it is also not possible to exclude the possibility that the observed leakage was attributable to blood seepage in this manner.Ultimately, the root cause of the event could not be determined, as limited investigation was possible given the condition of the returned device.

• Brand Name: CARBOSEAL VALSALVA ASCENDING AORTIC PROSTHESIS
• Type of Device: HEART VALVE, MECHANICAL
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia 13040 ; IT 13040
• Manufacturer (Section G): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 7047621
• MDR Text Key: 92588107
• Report Number: 3005687633-2017-00116
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057013569
• UDI-Public: (01)08022057013569(240)CP-027(17)200901
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P900060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/09/2020
• Device Model Number: CP-027
• Device Catalogue Number: CP-027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2017
• 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): Required Intervention