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

Model Number 9-PDAP-05-04-L

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/28/2020

Event Type  Injury  

Manufacturer Narrative

An event of embolization of a 05-04mm piccolo was reported.An amplatzer vascular plug was implanted in an off-label use instead.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 05-06, longer than the embolized 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, however the implantation of a smaller than recommended device may have contributed.Please note, per the instructions for use for amplatzer vascular plug "the safety and effectiveness of this device for cardiac uses (for example, patent ductus arterious or paravalvular leak closures) and neurological uses have not been established".

Event Description

On (b)(6) 2020, a 5-4 amplatzer piccolo was selected for implant for a (b)(6) month old, (b)(6) kg patient with a patent ductus arteriosus (pda) dimension of: 3.1 mm minimal diameter, 4.75 mm diameter at aortic ampulla, and 12mm in length.The device embolized 2 to 3 hours after the device was released and embolized to the right pulmonary artery.The device was snared and a 8mm vascular plug was implanted instead.There were no complications and consequences to the patient.The patient is stable.

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: 9739352
• MDR Text Key: 181823836
• Report Number: 2135147-2020-00073
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 05415067031044
• UDI-Public: 05415067031044
• 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
• Type of Report: Initial,Followup
• Report Date: 12/20/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 9-PDAP-05-04-L
• Device Catalogue Number: 9-PDAP-05-04-L
• Device Lot Number: 6955230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/28/2020
• Initial Date FDA Received: 02/21/2020
• Supplement Dates Manufacturer Received: 11/10/2020
• Supplement Dates FDA Received: 12/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 3 MO
• Patient Weight: 3