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

Model Number	9-PDAP-03-02-L
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Tricuspid Insufficiency (2111)
Date of Event	06/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem 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.
Additional 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
• Common Device Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10276106
• Report Number: 2135147-2020-00316
• Device Sequence Number: 1265339
• Product Code: MAE
• UDI-Device Identifier: 05415067030979
• UDI-Public: 05415067030979
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• 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
• Initial Date Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 09/25/2020; 11/10/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 09/30/2020; 12/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 DA
• Patient Weight: 1