MAUDE Adverse Event Report: HEART VALVES SANTA ANA FREESTYLE AORTIC ROOT BIOPROSTHESIS; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number FR995-25

Device Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190); Material Split, Cut or Torn (4008)

Patient Problems Hemorrhage/Bleeding (1888); Blood Loss (2597); No Code Available (3191)

Event Date 06/05/2018

Event Type  Injury  

Manufacturer Narrative

Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during the initial implant of this bioprosthetic valve and after being fully sutured into place, there was a tear in the proximal skirt which resulted in bleeding near the septal muscle.As a result, the valve was explanted and another valve was successfully implanted in its place.No additional adverse patient effects were reported. .

Manufacturer Narrative

Description of event updated.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during the initial implant of this bioprosthetic valve and after being fully sutured into place, there was a tear in the proximal skirt which resulted in bleeding near the septal muscle.As a result, the valve was explanted and another valve was successfully implanted in its place.This led to an extended time on bypass, and post operative, renal insufficiency was identified that led to a prolonged stay in the intensive care unit (icu).No additional adverse patient effects were reported. .

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, visual examination revealed that the myocardial tissue was torn at approximately 1cm in length, along the inflow margin of attachment in the left right inferior coaptive area.The stitching line was intact, however the affected sewing ring was everted.The stitches were removed which revealed tissue under the cloth above the stitching line.All leaflets were in the open position and were flexible and intact.All commissures were intact.There were 2 modifications made to the aortic wall.Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Per the valve instructions for use (ifu) in the ¿device implantation¿ section states ¿take care not to evert (roll outward) the inflow end of the bioprosthesis when suturing the valve to the patient¿s annulus.Eversion could damage the valve tissue.¿ and in section 5.0 ¿caution: do not invert the bioprosthesis when suturing.Inversion may result in elongated suture holes, tears, and/or distortion leading to stenosis and incompetence.¿ based on the received information and the returned product analysis, the probable cause of the torn myocardium tissue was due to the user everting the inflow sewing ring during implantation.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: FREESTYLE AORTIC ROOT BIOPROSTHESIS
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 7710427
• MDR Text Key: 114711446
• Report Number: 2025587-2018-01818
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2022
• Device Model Number: FR995-25
• Device Catalogue Number: FR995-25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2017
• 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
• Patient Age: 43 YR