MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL CARBOSEAL VALSALVA ASCENDING AORTIC PROSTHESIS; HEART VALVE, MECHANICAL

Model Number CP-029

Device Problems Detachment of Device or Device Component (2907); Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Chest Pain (1776); Insufficient Information (4580)

Event Date 01/04/2021

Event Type  Injury  

Event Description

The manufacture was informed of the event through the patient tracking department.Based on the information reported in the patient implant form, a carboseal valsalva cp-029 was implanted on (b)(6) 2017 and explanted on (b)(6) 2021, to be replaced by a similar device cp-029.No further information is presently available.No allegation of a device malfunction nor of a serious injury was received from the site regarding this event.

Manufacturer Narrative

Based on the additional information, there are strong patient's factors (marfan syndrome, previous aortic dissection treated in 2018 and covid-positive) that could have caused or contributed to the reported event of bacteremia and aortic dissection.Therefore, considering the information presently available and the investigation performed, the root cause of the event can be reasonably traced to the patient's specific conditions.The manufacturer is correcting the report previously sent to include the results of the device investigations performed: 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.The conclusions previously stated remains unchanged: based on the additional information, there are strong patient's factors (marfan syndrome, previous aortic dissection treated in 2018 and covid-positive) that could have caused or contributed to the reported event of bacteremia and aortic dissection.Therefore, considering the information presently available and the investigation performed, the root cause of the event can be reasonably traced to the patient's specific conditions.The manufacturer is submitting a correction to revise the health effect clinical and device problem codes.The remainder of the information previosuly submitted is unchanged.

Event Description

The manufacturer was informed of the event through the patient tracking department.Based on the information reported in the patient implant form, a carboseal valsalva cp-029 was implanted on (b)(6) 2017 and explanted on (b)(6) 2021, to be replaced by a similar device cp-029.No further information is presently available.No allegation of a device malfunction nor of a serious injury was received from the site regarding this event.Per additional information received, it was reported that the patient clinical history includes marfan syndrome (dx as a child), aortic root aneurism s/p bentall with cabrol modification, debakey type iii dissection s/p urgent tevar repair on (b)(6) 2018, osteoarthritis, hypertension, retinal detachment and gout.The patient was admitted on (b)(6) 2020 with c/o chest pain and the hospital course was complicated by covid status, aki, oxygen requirement and supra and sub therapeutic inr.The patient was found to have mssa bacteremia.The patient was treated with iv antibiotics and a decision was made for the patient to recover from covid symptoms and get a ct scan in 4 weeks.The patient presented back with fever and chills and chest pain.A repeated cat scan showed hematoma/fluid collection around the previously placed aortic root valve conduit.The results of the pet were consistent with infection of the graft and periaortic tissue.The patient was treated with iv antibiotics but the symptoms did not improve and a decision was made to perform a higher risk reoperation in an infected space.The intraoperative findings showed a complete dehiscence of the aortic root valve conduit where there was a lot of infected material around the valve conduit and that had led to the dehiscence of the valve.The procedure was completed with a new carboseal valsalva.Post procedure, there was no perivalvular leak.The patient was moved to the icu in stable conditions.No complications were noted.

• Brand Name: CARBOSEAL VALSALVA ASCENDING AORTIC PROSTHESIS
• Type of Device: HEART VALVE, MECHANICAL
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada crescentino; saluggia, vercelli
• MDR Report Key: 11793434
• MDR Text Key: 251211136
• Report Number: 1718850-2021-01071
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057013576
• UDI-Public: (01)08022057013576(240)CP-029(17)180930
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 04/09/2021,07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: CP-029
• Device Catalogue Number: CP-029
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/29/2021
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2021
• Date Manufacturer Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR