MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER STEERABLE DELIVERY SHEATH; CATHETER, PERCUTANEOUS

Catalog Number	ASDS-14F-075
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a 28mm amplatzer amulet left atrial appendage occluder was selected for implant on (b)(6) 2023 using a 14f amplatzer steerable delivery sheath.The patient had a pre-existing condition of atrial fibrillation and was noted to have a severely enlarged left atrial appendage (laa).The largest orifice of the appendage was measured at 36mm.The patient's activated clotting time (act) levels were over 250 seconds.During implant, the device was determined to be too small and was removed from the patient and replaced with a new 31mm amplatzer amulet left atrial appendage occluder.During implant it was noted that there were issue with air bubbles within the sheath of the device.The device was removed from the patient and replaced with a new 31mm amplatzer amulet left atrial appendage occluder.The device was re-captured three times to position the device into an ideal place.The device was implanted.Upon meeting close criteria, it was noted that while there was no flow detected past the lobe, there was some flow noted past the disc.It was determined that there was no way to close the gap between the disc and the coumadin ridge.A next-sized up disc would have encroached on the mitral inflow.The 6mm leak was deemed acceptable, and the device remained implanted.On (b)(6) 2024, during the one year follow-up transesophageal echocardiography (tee) a thrombus was detected.The patient was put back on a full dosage of eliquis (apixiban).A follow-up tee was scheduled in 3 months.It was thought that the thrombus was caused due to the correlation between a severely enlarged laa and atrial fibrillation.The patient status was stable.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of air/gas in the device (air in the sheath) was reported.A returned device assessment could not be performed as the device 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.Information from the field indicated that there were issue with air bubbles within the sheath of the device.The device was removed from the patient and replaced with a new amplatzer amulet left atrial appendage occluder.The cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that a 28mm amplatzer amulet left atrial appendage occluder was selected for implant on (b)(6) 2023 using a 14f amplatzer steerable delivery sheath.The patient had a pre-existing condition of atrial fibrillation and was noted to have a severely enlarged left atrial appendage (laa).The largest orifice of the appendage was measured at 36mm.The patient's activated clotting time (act) levels were over 250 seconds.During implant, the device was determined to be too small and was removed from the patient and replaced with a new 31mm amplatzer amulet left atrial appendage occluder.During implant it was noted that there were issue with air bubbles within the sheath of the device.The device was removed from the patient and replaced with a new 31mm amplatzer amulet left atrial appendage occluder.The device was re-captured three times to position the device into an ideal place.The device was implanted.Upon meeting close criteria, it was noted that while there was no flow detected past the lobe, there was some flow noted past the disc.It was determined that there was no way to close the gap between the disc and the coumadin ridge.A next-sized up disc would have encroached on the mitral inflow.The 6mm leak was deemed acceptable, and the device remained implanted.On (b)(6) 2024, during the one year follow-up transesophageal echocardiography (tee) a thrombus was detected.The patient was put back on a full dosage of eliquis (apixiban).A follow-up tee was scheduled in 3 months.It was thought that the thrombus was caused due to the correlation between a severely enlarged laa and atrial fibrillation.The patient status was stable.

• Brand Name: AMPLATZER STEERABLE DELIVERY SHEATH
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG#3007113487; 177 county road b east; st. paul MN 55117 1789
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19134404
• Report Number: 2135147-2024-01736
• Device Sequence Number: 4658179
• Product Code: DQY
• UDI-Device Identifier: 05415067036025
• UDI-Public: (01)05415067036025(17)230331(10)8426711
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K212026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: ASDS-14F-075
• Device Lot Number: 8426711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/28/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZER AMULET LAA OCCLUDER, 9-ACP2-010-028
• Patient Age: 71 YR
• Patient Sex: Unknown