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

Catalog Number	9-PDAP-04-02-L
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	07/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2024, a 4/2 amplatzer piccolo occluder was chosen for implant in a 5 week old, 1.26kg patient to close a patent ductus arteriosus (pda) with the following dimensions: length of 10mm and 2.9mm at minimum.During the procedure, there was difficult obtaining access to the site which was resolved.There was an issue cannulating the pda but it was eventually crossed.An angiogram measured the pda dimensions.The piccolo occluder was deployed.Around this time, the patient became bradycardic and hypotensive.It was thought that the delivery sheath was tented open with the device being deployed but prior to release.The device was recaptured, and the bradycardia and hypotension improved.Echocardiogram was then set up, and pericardial effusion was observed near the right atrium.The patient was stable, and the decision was made to deploy the device once more.During second deployment, the patient became unstable once again, and the device was removed.Cardiac tamponade was present.A pericardiocentesis was performed.Autotransfusion was performed through the delivery sheath.The patient became severely bradycardic, and cardiopulmonary resuscitation (cpr) was performed.The decision was made to send the patient to open heart surgery.A small hole was found in the anterior aspect of the right atrium.The hole was closed surgically.Efforts were made to obtain normal sinus rhythm and to return the patient's oxygen saturation and blood pressure.After an hour of working, the decision was made to stop efforts.The patient was alive, but the expectation was that the patient would expire once medications wore off.The patient status was reported as unknown.
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 implant-related tissue damage, perforation, bradycardia, hypotension, pericardial effusion, cardiac tamponade was reported.A returned device inspection, to rule out any device-related causes, 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.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on the available information, the cause of the reported implant-related tissue damage, perforation, pericardial effusion, and cardiac tamponade could not be conclusively determined.It is possible the reported issue of cannulating the pda contributed to the reported complications.However, this could not be confirmed.The reported bradycardia and hypotension appear to be a cascading effect of procedural complication.The reported unexpected medical intervention was a result of case-specific circumstances as pericardiocentesis, cpr, and autotransfusion were performed.The reported surgical intervention was a result of case-specific circumstances as the perforation was repaired surgically.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: AMPLATZER PICCOLO
• 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: 19883091
• Report Number: 2135147-2024-03709
• Device Sequence Number: 4148765
• Product Code: MAE
• UDI-Device Identifier: 05415067031006
• UDI-Public: (01)05415067031006(17)280229(10)8942691
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 10/11/2024

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 Catalogue Number: 9-PDAP-04-02-L
• Device Lot Number: 8942691
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 08/01/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2023
• 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 TORQVUE LP CATHETER, 9-TVLPC4F90/080
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 1 MO
• Patient Sex: Female
• Patient Weight: 1 KG