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

Catalog Number UNK AMPLATZER DUCT OCCLUDER II

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

Patient Problems Unspecified Infection (1930); Inflammation (1932); Pneumonia (2011); Sepsis (2067)

Event Date 03/01/2007

Event Type  Injury  

Event Description

The article, ¿amplatzer occluders for effective non-surgical management of bronchopleural fistulae¿, was reviewed.The article presented a retrospective single center study to assess the safety and efficacy of bronchopleural fistulae closure with amplatzer occluder devices over 14 years.Devices included in this study included amplatzer duct occluder ii and amplatzer vascular plug ii.The article concluded amplatzer occluders are a safe modality for non-surgical bronchopleural fistulae management with ease of placement under moderate sedation and flexible bronchoscopy with good short- and long-term effectivity.[(b)(6)].

Manufacturer Narrative

Summarized patient outcomes/complications of retrospective single center study to assess the safety and efficacy of bronchopleural fistulae closure with amplatzer duct occluder ii and amplatzer vascular plug ii devices over 14 years were reported in a research article "amplatzer occluders for effective non-surgical management of bronchopleural fistulae¿ in a subject population with multiple co-morbidities including malignant neoplasm of the lung, infection (post transplantation, lung abscess, mycobacterium, infection due to congenital anomaly, empyema), chronic obstructive pulmonary disease, granulomatosis with polyangiitis, malignant neoplasm of the esophagus, interstitial lung disease, cystic fibrosis, metastasis, hemoptysis, osler weber rendu, prior pneumonectomy, lobectomy, wedge resection.No procedural or immediate post-procedural complications or deaths were encountered.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 DUCT OCCLUDER II
• Type of Device: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17862555
• MDR Text Key: 324823993
• Report Number: 2135147-2023-04294
• Device Sequence Number: 1
• Product Code: MAE
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: P020024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK AMPLATZER DUCT OCCLUDER II
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2023
• 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): Required Intervention