MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER DUCT OCCLUDER II ADDITIONAL SIZES; TRANSCATHETER SEPTAL OCCLUDER

Device Problems Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)

Patient Problems Anemia (1706); Embolism (1829)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, out of 59 patients implanted with a amplatzer duct occluder ii additional sizes, three patients had the device embolize, and they were removed.On patient had a larger sized device implanted, one had a competitors device implanted, and the last had the defect surgically closed.Four of the 59 patients required blood transfusions after the procedure.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.Please note, per the instructions for use, 600419-004 revision a "the amplatzer duct occluder ii additional sizes is contraindicated for patients who weigh less than 6 kg".

Event Description

It was reported through a research article identifying amplatzer duct occluder type ii additional sizes (adoii as) that may be related to device embolization.Specific patient information is documented as unknown.Details are listed in the article, titled "ductal closure in infants under 6 kg including premature infants using amplatzertm duct occluder type two additional sizes: a single-centre experience in south africa".It was reported in the article that 59 patients who weighed less than 6kg underwent patent ductus arteriosus (pda) closure from june 2011 to june 2017.The median weight of the patients at closure was 3.6kg (range: 900g - 5.8kg).The median ductal diameter was 1.9mm (range: 1.0-3.4mm).It was reported that patients with other congenital heart diseases requiring surgery and those that had severe congenital abnormalities were excluded from the study.No vascular complications were reported.Device embolization occurred in three patients and all devices were retrieved via snare.In addition, four patients required post-implant blood transfusions.

• Brand Name: AMPLATZER DUCT OCCLUDER II ADDITIONAL SIZES
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10083059
• MDR Text Key: 192153358
• Report Number: 2135147-2020-00185
• Device Sequence Number: 1
• Product Code: MAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 12/21/2020

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?: Yes
• Device Operator: Health Professional
• 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: 4 MO
• Patient Weight: 3