MAUDE Adverse Event Report: ST. JUDE MEDICAL CATD AMPLATZER PFO OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number 9-PFO-025

Device Problem Obstruction of Flow (2423)

Patient Problems Ischemia (1942); Thrombus (2101)

Event Date 09/15/2019

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2018, a 25mm amplatzer pfo occluder was implanted.On (b)(6) 2019, a check with tee was performed and showed the device in normal position without evidence of thrombi or residual shunt.On (b)(6) 2019, the patient experienced cerebral ischemia, transient hyposthenia of the left upper limb, transient dysarthria and deviation to the left of rima oris.Additionally, thrombus was detected on the device by tee.On (b)(6) 2019, the device was explanted and the defect was closed with direct suture.Upon explant, one thrombus was observed on the right screw and another thrombus was observed on the left pin (radiopaque marker at the left disc).

Manufacturer Narrative

The thrombus seen at explant could not be confirmed.Neoendothealization was present on both discs, however no thrombus was identified on any portion of the device, including the central screw of the left and right atrial aspects.No acute inflammation was present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.The cause of the reported event could not be conclusively determined.

Event Description

On (b)(6) 2018, a 25mm amplatzer pfo occluder was implanted.On (b)(6) 2019, a check with tee was performed and showed the device in normal position without evidence of thrombi or residual shunt.On (b)(6) 2019, the patient experienced cerebral ischemia, transient hyposthenia of the left upper limb, transient dysarthria and deviation to the left of rima oris.Additionally, thrombus was detected on the device by tee.On (b)(6) 2019, the device was explanted and the defect was closed with direct suture.Upon explant, one thrombus was observed on the right screw and another thrombus was observed on the left pin (radiopaque marker at the left disc).

• Brand Name: AMPLATZER PFO OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ST. JUDE MEDICAL CATD; 4 robbins drive; westford MA 01886
• Manufacturer (Section G): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9182656
• MDR Text Key: 162461743
• Report Number: 2135147-2019-00310
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806011288
• UDI-Public: 00811806011288
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P120021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 9-PFO-025
• Device Catalogue Number: 9-PFO-025
• Device Lot Number: 6570231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2018
• 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