MAUDE Adverse Event Report: ST. JUDE MEDICAL CATD AMPLATZER PFO OCCLUDER; CARDIAC OCCLUSION DEVICE

Model Number 9-PFO-030

Device Problem Failure to Disconnect (2541)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/09/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

(b)(6) 2019 jl: additional information received on (b)(4) 2019 indicated that the third 30mm amplatzer pfo (lot #: 6498377) was successfully implanted using a new 9f amplatzer delivery system (lot #: 7073534).The user is unsure why the second pfo occluder was unable to be unscrewed from the delivery cable; therefore utilized a new delivery system.The user does allege a clinically significant prolonged procedure time.On (b)(6) 2019, a 30mm amplatzer pfo occluder (pfo) was selected for implant.However, after deploying, the left atrial disk did not enfold correctly and remained in a "balloon-like" form.The device was recaptured, removed, and exchanged with a new 30mm amplatzer pfo (lot #: 6883110).The second device was placed correctly, but did not unscrew/detach from the delivery cable.The second device was recaptured, removed, and exchanged with a new 30mm amplatzer pfo (lot #: unknown), which was successfully implanted.No patient consequences were reported.

Manufacturer Narrative

The reported event of inability to release the device from the delivery cable could not be confirmed.The investigation confirmed the device met functional specifications when analyzed at abbott.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

17 september 2019 jl: additional information received on 11 september 2019 indicated that the third 30mm amplatzer pfo (lot #: 6498377) was successfully implanted using a new 9f amplatzer delivery system (lot #: 7073534).The user is unsure why the second pfo occluder was unable to be unscrewed from the delivery cable; therefore utilized a new delivery system.The user does allege a clinically significant prolonged procedure time.On (b)(6) 2019, a 30mm amplatzer pfo occluder (pfo) was selected for implant.However, after deploying, the left atrial disk did not enfold correctly and remained in a "balloon-like" form.The device was recaptured, removed, and exchanged with a new 30mm amplatzer pfo (lot #: 6883110).The second device was placed correctly, but did not unscrew/detach from the delivery cable.The second device was recaptured, removed, and exchanged with a new 30mm amplatzer pfo (lot #: unknown), which was successfully implanted.No patient consequences were reported.Additional information is requested.

• Brand Name: AMPLATZER PFO OCCLUDER
• Type of Device: CARDIAC OCCLUSION DEVICE
• 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: 9162200
• MDR Text Key: 162951632
• Report Number: 2135147-2019-00309
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 9-PFO-030
• Device Catalogue Number: 9-PFO-030
• Device Lot Number: 6883110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2019
• 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