MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER DUCT OCCLUDER; OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Catalog Number	9-PDA-006
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	10/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2024, an 10-8mm amplatzer duct occluder was selected for implant.During the procedure, it was deemed too small, so a 10-8mm amplatzer duct occluder was chosen with a 6f sheath.While positioning the second device, it was found to be too large.It was decided to retract and remove the device and for the patient to have surgical repair.However, the device was unable to be retracted back into the sheath.According to one of the operators, the correct indication would be a 7f sheath for the 10-8mm amplatzer duct occluder.The sheath¿s flexible tip was causing the device to bend inwards towards the lumen during retraction.To resolve this a multiple catheters were used in an attempt to get the prothesis retracted.Removal was successful by use of an 8f sheath via a venous route.During the procedure, the patient became hemodynamically unstable due to prolonged sedation.The patient required a blood transfusion due to venous bleeding caused by the repeated insertion and removal of material and the duration of the procedure.The patient had also experienced low cardiac output.Surgery was carried out the following day for surgical repair of the defect.There was no clinically significant delay, but the patient was hemodynamically unstable.There was a prolonged hospitalization in this case and the patient is doing well.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
It was reported while positioning the device, it was found to be too large.Reportedly, the sheath¿s flexible tip was causing the device to bend inwards towards the lumen during retraction.To resolve this a multiple catheters were used in an attempt to get the prothesis retracted.A returned device inspection could not be performed as the device was not returned for analysis.Unexpected medical intervention is an case specific for blood transfusion.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.Based on received information, 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 on (b)(6) 2024, an 10-8mm amplatzer duct occluder was selected for implant.During the procedure, it was deemed too small, so a 10-8mm amplatzer duct occluder was chosen with a 6f sheath.While positioning the second device, it was found to be too large.It was decided to retract and remove the device and for the patient to have surgical repair.However, the device was unable to be retracted back into the sheath.According to one of the operators, the correct indication would be a 7f sheath for the 10-8mm amplatzer duct occluder.The sheath¿s flexible tip was causing the device to bend inwards towards the lumen during retraction.To resolve this a multiple catheters were used in an attempt to get the prothesis retracted.Removal was successful by use of an 8f sheath via a venous route.During the procedure, the patient became hemodynamically unstable due to prolonged sedation.The patient required a blood transfusion due to venous bleeding caused by the repeated insertion and removal of material and the duration of the procedure.The patient had also experienced low cardiac output.Surgery was carried out the following day for surgical repair of the defect.There was no clinically significant delay, but the patient was hemodynamically unstable.There was a prolonged hospitalization in this case and the patient is doing well.
Additional Manufacturer Narrative
It was reported while positioning the device, it was found to be too large.Reportedly, the sheath¿s flexible tip was causing the device to bend inwards towards the lumen during retraction.To resolve this a multiple catheters were used in an attempt to get the prothesis retracted.A returned device inspection could not be performed as the device was not returned for analysis.Unexpected medical intervention is an case specific for blood transfusion.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.Based on received information, 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 on (b)(6) 2024, an 6-4mm amplatzer duct occluder was selected for implant.During the procedure, it was deemed too small, so a 10-8mm amplatzer duct occluder was chosen with a 6f sheath.While positioning the second device, it was found to be too large.It was decided to retract and remove the device and for the patient to have surgical repair.However, the device was unable to be retracted back into the sheath.According to one of the operators, the correct indication would be a 7f sheath for the 10-8mm amplatzer duct occluder.The sheath¿s flexible tip was causing the device to bend inwards towards the lumen during retraction.To resolve this a multiple catheters were used in an attempt to get the prothesis retracted.Removal was successful by use of an 8f sheath via a venous route.During the procedure, the patient became hemodynamically unstable due to prolonged sedation.The patient required a blood transfusion due to venous bleeding caused by the repeated insertion and removal of material and the duration of the procedure.The patient had also experienced low cardiac output.Surgery was carried out the following day for surgical repair of the defect.There was no clinically significant delay, but the patient was hemodynamically unstable.There was a prolonged hospitalization in this case and the patient is doing well.

• Brand Name: AMPLATZER DUCT OCCLUDER
• Common Device Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20727622
• Report Number: 2135147-2024-05866
• Device Sequence Number: 8989431
• Product Code: MAE
• UDI-Device Identifier: 00811806011134
• UDI-Public: (01)00811806011134(17)260228(10)7903733
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/30/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Catalogue Number: 9-PDA-006
• Device Lot Number: 7903733
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 12/10/2024; 01/24/2025
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 12/27/2024; 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown