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

Model Number 9-PDA2AS-05-04-L

Device Problems Off-Label Use (1494); Obstruction of Flow (2423)

Patient Problems Sepsis (2067); Stenosis (2263); Heart Failure/Congestive Heart Failure (4446)

Event Type  Death  

Manufacturer Narrative

As reported in a research article, an amplatzer duct occluder ii additional sizes was implanted to occlude a patent ductus arteriosus between september 2014 to december 2019 in a (b)(6) old patient weighing (b)(6) grams; an event of left pulmonary artery stenosis, coarctation of the aorta, device explant, sepsis, and patient death was reported.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

The article,  transcatheter closure of patent ductus arteriosus in premature infants with very low birth weight, was reviewed.This research article reported 25 premature infants that underwent transcatheter closure of patent ductus arteriosus(pda) between september 2014 to december 2019.A 5/4 amplatzer duct occluder ii as was successfully implanted in a (b)(6) old female infant weighing (b)(6) gm with the following pda dimensions: minimal diameter of 2.9mm and a pda length of 5.3mm.The procedure was completed smoothly and the patient's initial condition was stable, the patient's condition progressively deteriorated.The patient developed left pulmonary artery stenosis (lpas) and coarctation of the aorta (coa).It was believed that the patient's condition may have been due to unstable pda status in premature infants in the first week.Although the surgeon removed the device successfully at 150 days after the procedure, the patient died because of sepsis at 163 days after intervention.It was reported that the patient's death was from progressive coa related to the procedure.Patient's comorbidities included oliguria, cardiomegaly, and pulmonary hemorrhage.The article concluded that performing transcatheter pda closure in symptomatic premature infants weighing more than 478 g is feasible using currently available devices; moreover, the procedure serves as an alternative to surgery.The primary and correspondence author of this article is jieh-neng wang, department of pediatrics, national cheng kung university hospital, college of medicine, national cheng kung university, tainan, taiwan with the corresponding email: jiehneng@mail.Ncku.Edu.Tw.

Manufacturer Narrative

As reported in a research article, an amplatzer duct occluder ii additional sizes was implanted to occlude a patent ductus arteriosus between september 2014 to december 2019 in a (b)(6) old patient weighing (b)(6) grams; an event of left pulmonary artery stenosis, coarctation of the aorta, device explant, sepsis, and patient death was reported.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.Please note, per the amplatzer duct occluder ii additional sizes instructions for use, artmt600034252 revision b "contraindications: the amplatzer¿ duct occluder ii additional sizes is contraindicated for patients.Who weigh less than 6 kg.Younger than 6 months of age." please note per the amplatzer duct occluder ii additional sizes instructions for use, artmt600034252 revision b, that for a pda with a minimum diameter of 2.9mm and a length of 5.3mm a 4-4mm piccolo is recommended per the sizing table.

• Brand Name: AMPLATZER DUCT OCCLUDER II ADDITIONAL SIZES
• Type of Device: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 11418654
• MDR Text Key: 234877643
• Report Number: 2135147-2021-00089
• Device Sequence Number: 1
• Product Code: MAE
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 2 DA