ABBOTT MEDICAL MASTERS SERIES HEART VALSALVA AORTIC VALVES GRAFT; HEART-VALVE, MECHANICAL
|
Back to Search Results |
|
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.
|
|
Search Alerts/Recalls
|
|
|