MAUDE Adverse Event Report: ABBOTT MEDICAL MASTERS SERIES HEART VALSALVA AORTIC VALVES GRAFT; HEART-VALVE, MECHANICAL

Model Number 27VAVGJ-515

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atrial Fibrillation (1729); Hematoma (1884); Pseudoaneurysm (2605); Vascular Dissection (3160); Respiratory Insufficiency (4462)

Event Date 04/09/2023

Event Type  Injury  

Event Description

As reported via legal documentation the patient had a left knee replacement on (b)(6) 2010.Approximately 6 years and 6 months after the initial procedure the patient had the first left knee revision on (b)(6) 2016 with another exactech knee system.Approximately 6 months after the first revision the patient had a second left knee revision on (b)(6) 2017 with another exactech knee system.Approximately 4 years and 1 month after the second revision the patient had a third left knee revision on (b)(6) 2021.After each of the left total knee replacement surgeries, plaintiff began to suffer from symptoms associated with the defects of exactech knee system as alleged in this complaint, including but not limited so synovitis with aseptic loosening, mechanical loosening, pain and lack of mobility.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

An event of hematoma, atrial fibrillation and bleeding was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.There was no allegation or malfunction about the abbott device or the procedure.

Event Description

Clinical information: (b)(6) - valved grafts pas, patient site id: (b)(6).It was reported that on (b)(6) 2023, a 27mm sjm masters series valsalva aortic valved graft was successfully implanted.There were no concomitant cardiac procedures performed during the same surgery.There were no intraprocedural adverse events or device deficiencies.On (b)(6) 2023, a computed tomography (ct) scan showed a mediastinal hematoma, which was reportedly due to post-operative coagulopathy.The patient's hospitalization was prolonged.Packed red blood cells (prbc) were administered on (b)(6) 2023.On (b)(6) 2023, patient had tracheostomy procedure due to respiratory failure.Patient went into atrial fibrillation with rapid ventricular response (rvr).The patient was returned to the intensive care unit (icu) and was hypotensive.Patient was administered anti-arrhythmic amiodarone and fluid bolus.Patient remained hypotensive.Patient was administered norepinephrine, and a synchronous cardioversion was performed which resulted in conversion to sinus rhythm.On (b)(6) 2023, a ct scan showed an aortic dissection, type b.On (b)(6) 2023, a thoracic endovascular aortic repair (tevar) was performed.On (b)(6) 2023, patient was discharged from the hospital.On (b)(6) 2023, patient presented with bloody drainage from left groin site, which was the access site for the tevar.The patient was re-admitted to the hospital.A ct scan showed a pseudoaneurysm measuring 3.97 cm by 2.97 cm with an active chamber of 2.22 cm by 1.39 cm in the left groin.Vascular surgery was consulted, and an open wound repair was performed on (b)(6) 2023.The patient status was reported as stable.

Manufacturer Narrative

An event of hematoma, atrial fibrillation and bleeding was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.There was no allegation or malfunction about the abbott device or the procedure.

Event Description

Clinical information: (b)(6) - valved grafts pas, patient site id: (b)(6).It was reported that on (b)(6) 2023, a 27mm sjm masters series valsalva aortic valved graft was successfully implanted.There were no concomitant cardiac procedures performed during the same surgery.There were no intraprocedural adverse events or device deficiencies.On (b)(6) 2023, a computed tomography (ct) scan showed a mediastinal hematoma, which was reportedly due to post-operative coagulopathy.The patient's hospitalization was prolonged.Packed red blood cells (prbc) were administered on (b)(6) 2023, patient had tracheostomy procedure due to respiratory failure.Patient went into atrial fibrillation with rapid ventricular response (rvr).The patient was returned to the intensive care unit (icu) and was hypotensive.Patient was administered anti-arrhythmic amiodarone and fluid bolus.Patient remained hypotensive.Patient was administered norepinephrine, and a synchronous cardioversion was performed which resulted in conversion to sinus rhythm.On (b)(6) 2023, patient was discharged from the hospital.On (b)(6) 2023, patient presented with bloody drainage from left groin site, which was the access site for the thoracic endovascular aortic repair (tevar).The patient was re-admitted to the hospital.A ct scan showed a pseudoaneurysm measuring 3.97 cm by 2.97 cm with an active chamber of 2.22 cm by 1.39 cm in the left groin.Vascular surgery was consulted, and an open wound repair was performed on (b)(6) 2023.The patient status was reported as stable.

• Brand Name: MASTERS SERIES HEART VALSALVA AORTIC VALVES GRAFT
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC. REG#2648612; 20 b st caguas west park; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16869409
• MDR Text Key: 314616524
• Report Number: 2135147-2023-01946
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2023
• Device Model Number: 27VAVGJ-515
• Device Catalogue Number: 27VAVGJ-515
• Device Lot Number: 8468973
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2022
• 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; Life Threatening; Hospitalization
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 137 KG
• Patient Race: Black Or African American