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

Model Number	OCCLUDER
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	04/27/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
This report is being conservatively reported as the cause of death and its relationship to the implant procedure and/or device remains unknown.It was reported that on 27 apr 2022, a 4mm by 2mm amplatzer piccolo occluder was chosen for implant for a (b)(6) patient with the following patent ductus arteriosus (pda) dimensions: minimal diameter 2.4mm, length of 12.2mm and diameter at aortic ampulla of 2.7mm.The delivery system used was a 4f amplatzer torqvue low profile catheter.Prior to the procedure, the patient was on ventilatory support and on intravenous (iv) support.During the procedure, the device was placed intraductal, and the results were satisfactory during both echocardiography and angiography.There was no difficulty implanting the device.Only heparinized saline was used in the procedure, and no heparin was administered during the procedure.The device was released, and the delivery system was removed.The patient then began to decompensate with low blood pressure and bradycardia.The patient was administered medication support, and cardiopulmonary resuscitation (cpr) was initiated.The patient was noted to have a new pericardial effusion, and the effusion was relieved with pericardiocentesis.The patient stabilized briefly, but the effusion soon reappeared.Cpr was initiated again.The cardiothoracic surgeon and the general surgeon were notified.The piccolo device was reexamined, and the device was found to be stable and in the same place.The patient vital signs were very labile, and the source of the effusion continued to be investigated.The pericardial effusion led to cardiac tamponade.The patient continued to decompensate and died on the procedure table.The implanter does not classify this death as being related to the performance of the implanted device.The cause of the pericardial effusion was unknown.The cause of death was hypotension and bradycardia.No additional information was provided.
Additional Manufacturer Narrative
An event of patient death due to hypotension and bradycardia after the device was implanted was reported.Information from the field indicated that prior to the implant procedure the patient was on ventilatory support and on intravenous support.The device was placed with satisfactory results and without any difficulty or extraneous manipulations of the device.The device remained stable and the operator did not classify the death as related to the performance of the device.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.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Na.
Event or Problem Description
N/a.

• 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: 14520353
• Report Number: 2135147-2022-00327
• Device Sequence Number: 15091030
• Product Code: MAE
• UDI-Device Identifier: 05415067031006
• UDI-Public: 05415067031006
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 07/27/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: OCCLUDER
• Device Catalogue Number: 9-PDAP-04-02-L
• Device Lot Number: 8192128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2022
• Supplement Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 05/27/2022
• Supplement Report FDA Received Date: 07/27/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZER TORQVUE LP CATHETER, 9-TVLPC4F90/080
• Outcome Attributed to Adverse Event: Death
• Patient Age: 20 DA
• Patient Sex: Female
• Patient Weight: 990 KG