MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER PFO OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number	PFO OCCLUDER
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	06/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2023, a 35mm amplatzer patent foramen ovale (pfo) occluder was chosen for implant using a 9f amplatzer trevisio delivery system.During procedure, heparin was administrated and the activated clotting time (act) levels of the patient was 372.The right atrial (ra) disc of the occluder was not flattening before release and had a bulbous deformation.The disc was flatted after release confirmed in fluoroscopy.There was no report of any interaction with cardiac structures during deployment and no report of any angulation/kink noticed with the delivery system.After the procedure, a pericardial effusion was noted.A pericardiocentesis was performed.Patient stayed overnight due to pericardiocentesis.After the procedure, the patient become hypotensive and transferred to the stretcher the physician mentioned pericardial effusion was not related to occluder and it was caused by one of the non-abbott wires while attempting to cross the septum.There was no clinically significant delay in procedure.The patient was discharged.
Additional Manufacturer Narrative
An event of device deformity was reported.A returned device inspection 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.There were no complaints associated with any other devices from the lot.Information from the field indicated that there was no anatomical interference, an 9f delivery sheath was used, and there was not any angulation or kink in the delivery system upon deployment.The cause of the reported incident could not be conclusively determined.There is no indication for a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
It was reported that on (b)(6) 2023, a 35mm amplatzer patent foramen ovale (pfo) occluder was chosen for implant using a 9f amplatzer trevisio delivery system.During procedure, heparin was administrated, and the activated clotting time (act) levels of the patient was 372.It was noted that the patient's heart was rotated.It was difficult to cross the septum during the transeptal puncture due to the patient anatomy.After the device was deployed, the right atrial (ra) disc of the occluder was not flatten and had a bulbous deformation.The device was released from the delivery cable and the disc was flatted, confirmed in fluoroscopy.There was no report of any interaction with cardiac structures during deployment and no report of any angulation/kink noticed with the delivery system.There was no clinically significant delay in procedure.After the procedure, the patient became hypotensive, and a pericardial effusion was noted.A pericardiocentesis was performed.Patient stayed overnight due to pericardiocentesis.The physician mentioned pericardial effusion was not related to occluder and it was caused by one of the non-abbott wires while attempting to cross the septum.The patient was discharged.

• Brand Name: AMPLATZER PFO OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• 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: 17226207
• Report Number: 2135147-2023-02853
• Device Sequence Number: 7076173
• Product Code: MLV
• UDI-Device Identifier: 00811806011301
• UDI-Public: 00811806011301
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P120021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 08/03/2023

1 Device was Involved in the Event

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: 09/30/2026
• Device Model Number: PFO OCCLUDER
• Device Catalogue Number: 9-PFO-035
• Device Lot Number: 8192122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2021
• 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
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 62 KG