MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER PFO OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number 9-PFO-035

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Palpitations (2467)

Event Date 09/27/2018

Event Type  Injury  

Manufacturer Narrative

An event of premature ventricular contractions was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

On (b)(6) 2018, a 35 amplatzer pfo occluder was successfully implanted in a (b)(6) year old female patient.Immediately after the procedure the patient reported palpitations which worsened on (b)(6) 2018, and sought medical attention but declined treatment with metoprolol.An ekg performed on (b)(6) 2018 showed sinus rhythm with frequent premature ventricular contractions and again the patient was offered metoprolol which the patient may accept.The status of the patient is unknown.(b)(6).

• Brand Name: AMPLATZER PFO OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8064945
• MDR Text Key: 126954775
• Report Number: 2135147-2018-00210
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806011301
• UDI-Public: 00811806011301
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 9-PFO-035
• Device Catalogue Number: 9-PFO-035
• Device Lot Number: 5712984
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2016
• 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): Hospitalization
• Patient Age: 34 YR