MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Catalog Number 9-ASD-014

Device Problems Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)

Patient Problems Dyspnea (1816); Pulmonary Edema (2020); Obstruction/Occlusion (2422); Foreign Body In Patient (2687); Pulmonary Hypertension (4460)

Event Date 02/13/2024

Event Type  Injury  

Event Description

The article, "late embolisation of atrial septal defect device to abdominal aorta", was reviewed.The article presented a case study of a 77-year-old female patient with a secundum atrial septal defect measuring 12x11mm with thin and hypermobile superior-rim and limited inferior and posterior rims (4-5mm).It was reported that on an unknown date in 2010, a 14mm amplatzer septal occluder was implanted.The patient was discharged on 6-months dual-antiplatelet therapy with good echocardiographic results at 2 and 12 months.It was then reported on an unknown date in 2022, the patient presented with dyspnea and edema.Transthoracic echocardiography revealed right chamber dilation and migration of the occluder, with residual left-right shunt and severe pulmonary hypertension.On an unknown date, the patient suffered a hip fracture and subsequent hemorrhagic shock.A computed tomography scan confirmed device embolization to the abdominal aorta at the renal arteries level, causing moderate stenosis but without restrictive flow.Right heart catheterization confirmed pulmonary hypertension, with systolic and mean pressures measuring 68 and 38 mmhg.It was also reported pulmonary vascular resistances (pvr) were elevated to 9 wood-units, while wedge-press remained normal.Due to patient's negative decision for open-surgery, unknown time-lapse of device embolization, and associated high morbidity and mortality risks, a non-operative management was chosen.The patient underwent close follow-up with regular imaging tests.The initiation of pulmonary vasodilators resulted in clinical improvement and a decrease in pvr (6-wu), with no migration/major stenosis in successive imaging tests.[the primary and corresponding author was miguel morales-garcia, cardiology department, virgen de las nieves university hospital, granada, spain, with corresponding email: (b)(6)] no peri-procedural complications were reported.Post-procedural complications included unexpected medical intervention, hospitalization, dyspnea, edema, pulmonary hypertension, obstruction/occlusion, foreign body in patient, device migration, device embolization, residual shunt.

Manufacturer Narrative

B3 - date of event is estimated.D4 - the udi number is not known as the part and lot numbers were not provided.Attachment: article titled "late embolisation of atrial septal defect device to abdominal aorta".Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

Summarized patient outcomes/complications of amplatzer septal occluder were reported in a research article in a subject population with atrial septal defect with thin and hypermobile superior-rim and limited inferior and posterior rims.Some of the complications reported were unexpected medical intervention and hospitalization due to dyspnea and edema, device migration with residual shunt, pulmonary hypertension, device embolization that caused obstruction.Foreign body in patient as the initiation of pulmonary vasodilators resulted in clinical improvement and with no migration/major stenosis in successive imaging tests.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18915192
• MDR Text Key: 337796789
• Report Number: 2135147-2024-01144
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-ASD-014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female