MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. ORBIS PROSTHETIC HEART VALVE; HEART VALVE, MECHANICAL

Model Number	A1-025
Medical Device Problem Code	Gradient Increase (1270)
Health Effect - Clinical Code	Ventricular Fibrillation (2130)
Date of Event	12/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device available but not yet received.
Event or Problem Description
On (b)(6) 2017 an avr was performed and an orbis prosthetic heart valve was implanted.When the patient was in icu post-procedure, they experienced ventricular fibrillation.The patient was returned to the operating room, and it was discovered that there was great resistance to the valve leaflets opening and closing.The device was explanted, and a new product was implanted.The patient then restored sinus rhythm, and was in icu under observation at the time the event was reported to the manufacturer.
Additional Manufacturer Narrative
The manufacturer received confirmation that the valve is not available for return.As such, no further investigation can be performed.As such, the root cause of the event cannot be determined.However, based on the results of the document review performed previously, no manufacturing deficits were identified.Device not available for return.
Additional Manufacturer Narrative
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.
Event or Problem Description
On 16 january 2018, additional information was received about patient outcome that the patient is doing fine.There was no indication about what was preventing the orbis leaflet from opening.No tee/tte at the time of detection of the event is available.

• Brand Name: ORBIS PROSTHETIC HEART VALVE
• Common Device Name: HEART VALVE, MECHANICAL
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc 13040 ; IT 13040
• MDR Report Key: 7198399
• Report Number: 3005687633-2018-00103
• Device Sequence Number: 16367845
• Product Code: LWQ
• UDI-Device Identifier: 08022057012470
• UDI-Public: (01)08022057012470(240)A1-025(17)210114
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/12/2018

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
• Operator of Device: Physician
• Device Expiration Date: 01/14/2021
• Device Model Number: A1-025
• Device Catalogue Number: A1-025
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/21/2017
• Supplement Date Received by Manufacturer: 01/16/2018; 03/28/2018
• Initial Report FDA Received Date: 01/16/2018
• Supplement Report FDA Received Date: 02/13/2018; 04/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention