MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER PICCOLO OCCLUDER; OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Model Number 9-PDAP-03-02-L

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Tricuspid Insufficiency (2111)

Event Date 06/19/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

On (b)(6) 2020, a 3-2 amplatzer piccolo was selected for implant for a (b)(6) old (b)(6) gram patient.The patient has a patent ductus arteriosus (pda) of: minimum diameter : 1.7mm, ampulla: 3.5mm, length: 6.0 - 7.0mm.The device was placed intraductal.Upon release, the device embolized to the pulmonary artery.The device was snared with a non-abbott device.While retrieving the occluder, the tricuspid valve was injured by the non-abbott sheath.The pda became smaller post procedure and is being monitored.The patient is stable with no further complications reported.

Manufacturer Narrative

Additional information for: g4, g7, h2, h3, h6, and h10.An event of embolization was reported.The investigation confirmed the device met functional and dimensional specifications when analyzed at abbott.Per the instruction for use, arten600042307 version b, that for a pda with a minimum diameter of 1.7mm and a length of 6-7mm a 3-2mm piccolo, the size of the embolized device, is recommended.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 incident could not be conclusively determined.A capa was initiated for further investigation on the device embolization, per internal procedures.

• Brand Name: AMPLATZER PICCOLO OCCLUDER
• Type of Device: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10276106
• MDR Text Key: 198881465
• Report Number: 2135147-2020-00316
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 05415067030979
• UDI-Public: 05415067030979
• Combination Product (y/n): N
• PMA/PMN Number: P020024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-PDAP-03-02-L
• Device Catalogue Number: 9-PDAP-03-02-L
• Device Lot Number: 7247249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 DA
• Patient Weight: 1