MAUDE Adverse Event Report: ST. JUDE MEDICAL (CVD-MINNETONKA) AMPLATZER DUCT OCCLUDER; OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Model Number	9-PDA-006
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further information regarding this event has been requested.If returned, investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2020 a ductus closure was performed with the reference device (b)(4) of the batch: 7176841 in a 4.7 mm lung duct, with an introducer of the reference (b)(4) of the batch: 7022729.According to closing instructions.At the time of deploying the device in the pulmonary part it was not configured well and took "cobra shape", which creates distrust in the specialist in its conformation and decides to remove it.It is checked on the table to verify and that it will conform well and it was ok.Again it is decided to pass it and for the second time it takes the shape form, that is, it charges, so the operator decides to change the device.In this case it is decided to change for a reference device (b)(4) of the lot: 7076987 that goes through the same introducer already mentioned and this device is very well conformed.The extra time in the implantation of the new device only took 15 minutes more in the total of the procedure and the patient at all times remained stable and went very well in the end.
Additional Manufacturer Narrative
Additional information sections: d10, h2, h3, h6, h10.The reported event of device deformation could not be confirmed.The investigation confirmed the device met visual and functional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported incident could not be conclusively determined.Please note, per the instructions for use, artmt "do not release the occluder from the delivery cable if: more than 3mm of the occluder extend into the pulmonary artery, left pulmonary artery flow is more than 3m/s or more than 75% greater than the velocity before cardiac catheterization, the occluder does not conform to its original configuration, or if the occluders position is unstable.If any of these conditions exists, recapture the occluder by advancing the sheath over the occluder.Redepoly the occluder.If the occluder's configuration or position remains unsatisfactory, recapture and replaced with a new one.".

• Brand Name: AMPLATZER DUCT OCCLUDER
• Common Device Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): ST. JUDE MEDICAL (CVD-MINNETONKA); 14901 deveau place; minnetonka MN 55345 2126
• MDR Report Key: 9813332
• Report Number: 2182269-2020-00025
• Device Sequence Number: 16460020
• Product Code: MAE
• UDI-Device Identifier: 00811806011134
• UDI-Public: 00811806011134
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/20/2020

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: 08/31/2024
• Device Model Number: 9-PDA-006
• Device Catalogue Number: 9-PDA-006
• Device Lot Number: 7176841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/28/2020
• Supplement Date Received by Manufacturer: 03/24/2020; 11/10/2020
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 04/10/2020; 12/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 34 DA
• Patient Weight: 60