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

Model Number 9-PDA2AS-04-02-L

Device Problems Migration or Expulsion of Device (1395); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

It was reported on an unknown date a 4/4mm amplatzer duct occluder ii was selected for implant.After deploying it was discovered it only partially occlude the defect.The device was removed and replaced with a 4/2mm amplatzer duct occluder ii (7598872).After placing the new device the physician was having difficulties deploying the device.Eventually the device was deployed into position however, shortly after the device embolized.The device was removed from the patient successfully and 5mm amplatzer vascular plug 4 was successfully implant.There was a delay in procedure requiring extended anesthetic.The patient was reported to be in stable condition and since has been discharged.Additional information is pending.

Manufacturer Narrative

An event of "difficulties deploying the device" and device embolization was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.Please note, per the amplatzer vascular plug 4 instructions for use, artmt100092327 revision a "indications and usage: the amplatzer¿ vascular plug 4 is indicated for arterial and venous embolization's in the peripheral vasculature.

• 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: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13054039
• MDR Text Key: 282609268
• Report Number: 2135147-2021-00587
• Device Sequence Number: 1
• Product Code: MAE
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9-PDA2AS-04-02-L
• Device Lot Number: 7598872
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2020
• 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