MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER DUCT OCCLUDER II ADDITIONAL SIZES; OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Model Number 9-PDA2AS-05-04-L

Device Problems Improper or Incorrect Procedure or Method (2017); Obstruction of Flow (2423)

Patient Problem Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, aortic obstruction and left pulmonary artery obstruction was noted during follow up after implantation with a 5-6 amplatzer piccolo.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 04-02, smaller than the implanted device.The cause of the reported event could not be conclusively determined, however the implantation of a larger than recommended device could have contributed.

Event Description

Reference manufacturing report number: 2135147-2020-00091, 2135147-2020-00092, 2135147-2020-00093, 2135147-2020-00094.It was reported through a research article identifying amplatzer piccolo that may be related to a severe left pulmonary artery obstruction.Details are listed in the article, titled "device deformation and left pulmonary artery obstruction after transcatheter patent ductus arteriosus closure in preterm infants." it was reported in the article that in (b)(6) 2016, 14 patients underwent transcatheter patent ductus arteriosus (pda) closure.An 20 days old patient that weight 1672 grams with pda diameter of 2.95mm and pda length of 8.02mm was implanted with a 5-6 amplatzer piccolo.During follow up, aortic obstruction and severe left pulmonary artery obstruction was observed.The patient was asymptomatic and no intervention was performed.

Manufacturer Narrative

Correction information for b5, d1, d4, g4, g7, and h10.As reported in a research article, aortic obstruction and left pulmonary artery obstruction was noted during follow up after device implantation.The results of the investigation are inconclusive since the device was not returned for analysis.The cause of the reported event could not be conclusively determined.Please note, per the instructions for use, 600419-004 version a, " the amplatzer duct occluder ii additional sizes is contraindicated for patients who weigh less than 6 kg and are younger than 6 months in age".

Event Description

It was reported through a research article identifying amplatzer ado ii may be related to a severe left pulmonary artery obstruction.Details are listed in the article, titled "device deformation and left pulmonary artery obstruction after transcatheter patent ductus arteriosus closure in preterm infants".It was reported in the article that in (b)(6) 2016, 14 patients underwent transcatheter patent ductus arteriosus (pda) closure.An 20 days old patient that weight 1672 grams with pda diameter of 2.95mm and pda length of 8.02mm was implanted with a 5-6 amplatzer ado ii.During follow up, aortic obstruction and severe left pulmonary artery obstruction was observed.The patient was asymptomatic and no intervention was performed.

Manufacturer Narrative

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

• Brand Name: AMPLATZER DUCT OCCLUDER II ADDITIONAL SIZES
• Type of Device: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9783125
• MDR Text Key: 183946277
• Report Number: 2135147-2020-00090
• 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: foreign,health professional,l
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-PDA2AS-05-04-L
• Device Catalogue Number: 9-PDAP-05-04-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): Other
• Patient Age: 20 DA
• Patient Weight: 2