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

Model Number AP-025

Device Problems Material Too Rigid or Stiff (1544); Incomplete Coaptation (2507)

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

Event Date 07/17/2017

Event Type  Injury  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

On (b)(6) 2017 during a procedure, the physician tested a carbo-seal ascending aortic prosthesis ap-025 by injecting water.The physician noted that the valve leaflet of the right side was stuck.The doctor then noted that the device appeared of normal function.In a conservative manner a new ap-025 was then used and implanted.One hour was added to the x-clamp time as a result of failure to implant.The patient was doing well after the procedure.

Manufacturer Narrative

The visual and gross inspections performed on the returned prosthesis confirmed the absence of pre-existing manufacturing defects.The hydrodynamic testing conducted on the functional assembly of the returned prosthesis confirmed that the device was showing normal leaflet kinematics and it did not reveal any anomaly during the open/close phases.Based on the performed analysis, which resulted in normal behavior of the functional assembly, the reported issue cannot be explained by any factor intrinsic to the involved device.The device was being used for treatment.Based on the performed investigations the valve showed normal functionality and the root cause can be deemed not valve related.

Manufacturer Narrative

A complete manufacturing and material records review for the device (sn# (b)(4)) 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 carboseal ap-025 sn (b)(4) was manufactured with the assembly sn (b)(4).The proof/functional test of the above mentioned assembly was successfully performed on (b)(6) 2017 according to the internal procedure.The assembly therefore meets the acceptance criteria of the proof/functional test, the principal device function test during manufacture.

• Brand Name: CARBO-SEAL ASCENDING AORTIC PROSTHESIS
• Type of Device: HEART VALVE, MECHANICAL
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L; strada crescentino snc; saluggia,, vc
• Manufacturer (Section G): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia,, vc
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 6798454
• MDR Text Key: 82862299
• Report Number: 3005687633-2017-00084
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 03/29/2018

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?: No
• Device Operator: Physician
• Device Expiration Date: 09/01/2020
• Device Model Number: AP-025
• Device Catalogue Number: AP-025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2017
• Initial Date FDA Received: 08/16/2017
• Supplement Dates Manufacturer Received: 08/24/2017; 09/28/2017; 03/09/2018
• Supplement Dates FDA Received: 09/19/2017; 10/24/2017; 03/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2017
• 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