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

Model Number 9-PDAP-05-02-L

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problems Embolism (1829); Stenosis (2263)

Event Date 01/17/2020

Event Type  Injury  

Manufacturer Narrative

An event of residual shunt, rotation of the device, pla stenosis, and device explant was reported.The results of the investigation are inconclusive since the device was not returned for analysis.A review of the measurements as reported from the field was performed.Per the sizing table in the instructions for use, arten600042307 version a, the correct size piccolo occluder for the measurements provided was 05-02, which was the size of the implanted device.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.The cause of the reported event could not be conclusively determined.

Event Description

It was reported that on (b)(6) 2020, a premature patient born at 28 weeks gestation underwent patent ductus arteriosus (pda) closure at 5 weeks of life and (b)(6) kg using a 05-02 amplatzer piccolo occluder.The pda was f-type with a diameter of 3.8 mm and a length of 8 to 10 mm.The occluder was implanted toward the pulmonary artery end of the pda but was completely intra-ductal.There was evidence of mild residual shunting around the device and the position of the device was stable.The device had a 10 o'clock orientation and was packed with both inferior disc edges compressed inward.On the first day following implant, echocardiography showed persistence of the residual shunt.On the fourth day following implant, a chest x-ray demonstrated that the device orientation shifted consisted with a rotation of the device to be pointing more superiorly.A repeat echocardiogram on (b)(6) 2020 showed that the shunt across the pda was gone, consistent with a likely spontaneous pda closure.Repeat chest x-ray on (b)(6) 2020 shows further rotation of the device.On (b)(6) 2020, there was evidence of left pulmonary artery stenosis with a velocity of 2.4 m/sec.The baby continues to do well and has a weight of (b)(6) kg.On (b)(6) 2020 (procedure day 63) the patient was taken to the cardiac catheterization lab and underwent an attempt to retrieve the device with a snare, but this was unsuccessful.The baby was subsequently taken to the operating room where the device was removed successfully from pulmonary artery without complications.

Manufacturer Narrative

Correction information for d2.Additional information for g4, g7, h2, h10.

• Brand Name: AMPLATZER PICCOLO OCCLUDER
• Type of Device: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10083508
• MDR Text Key: 193302788
• Report Number: 2135147-2020-00218
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 05415067031037
• UDI-Public: 05415067031037
• Combination Product (y/n): N
• PMA/PMN Number: P020024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-PDAP-05-02-L
• Device Catalogue Number: 9-PDAP-05-02-L
• Device Lot Number: 7253333
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 104 DA
• Patient Weight: 2