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

Model Number 9-PDAP-04-04-L

Device Problems Migration or Expulsion of Device (1395); Off-Label Use (1494); Obstruction of Flow (2423)

Patient Problems Vasoconstriction (2126); Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

An event of migration and protrusion into the aorta of the 4-4 piccolo device was reported.The piccolo was used off label in a patient under 700 grams.A more comprehensive assessment could not be performed as 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 a 5-2mm, the size of the initial device which was attempted to be implanted but was found to be too large for the size of the patient.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 event could not be conclusively determined.A capa was initiated for further investigation on the device migration, per internal procedures.Per the instructions for use, arten600042307 version a, "contraindications: weight < 700 grams at time of the procedure".

Event Description

On (b)(6) 2020, an 11 week 580 grams patient with a patent ductus arteriosus (pda) of the following dimensions: 3.5 mm diameter at pulmonary end and 6.0 mm diameter at the aortic end; length 8 to 10 mm underwent attempted implantation of a 5-2 amplatzer piccolo.The device was mis-sized too large and exchanged for a 4-4 amplatzer piccolo.There was some difficulty in getting the device in position, but ultimately the device was placed successfully within the intra-ductal position.Seven days post procedure creatinine increased and urine output decreased with evidence of aortic protrusion based on echocardiography doppler study.At 1-week post implant the device further migrated into the aorta with the aortic disc obstructing blood flow, possibly caused by spontaneous ductal constriction at the pulmonary end, that led to extrusion of the device posteriorly into the aorta.The infant was taken to the cardiac catherterization laboratory and underwent successful stent placement to relieve the aortic obstruction via the carotid artery.The infant recovered post-procedure and is doing clinically well.

• 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: 10360254
• MDR Text Key: 201551232
• Report Number: 2135147-2020-00355
• Device Sequence Number: 1
• Product Code: MAE
• 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: 08/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-PDAP-04-04-L
• 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: 11 WK