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

Model Number 9-PDAP-05-04-L

Device Problems Migration or Expulsion of Device (1395); Off-Label Use (1494)

Patient Problems Embolism (1829); No Consequences Or Impact To Patient (2199)

Event Date 06/10/2020

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 5-4 amplatzer piccolo was implanted in a 3 month and 30 days old patient using a 4f 80cm amplatzer torqvue lp.The patient has the following pda dimention: minimal diameter: 3.17mm, diameter at aortic ampulla: 6.99mm, and length: 4.33mm.The device was placed extraductal on the pulmonary aortic disk side.After implanting the device and waiting for the general anesthesia to wear off, the patient cried hard and wriggled.When the physician checked the transthoracic echocardiogram (tte) for the piccolo, the piccolo was not located where it was implanted.The device had become dislodged.The patient was put under general anesthesia immediately and the piccolo was removed percutaneously with a snare catheter.A 6-4 amplatzer duct occluder was implanted instead and the procedure was completed with no further complications.

Manufacturer Narrative

Correction information for d2.Additional information for g4, g7, h2, h10.

Manufacturer Narrative

An event of embolization of the 5-4 piccolo device was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.A review of the measurements as reported from the field was performed.Per the sizing table in the instructions for use, arten600042307 version a, the correct size piccolo occluder for the measurements provided was 5-6 piccolo, larger than the embolized device.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported event could not be conclusively determined.A capa was initiated for further investigation on the device embolization per internal procedures.

Manufacturer Narrative

An event of embolization of the 5-4 piccolo device was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.A review of the measurements as reported from the field was performed.Per the sizing table in the instructions for use, arten600042307 revision b, the correct size piccolo occluder for the measurements provided was 5-4 piccolo, the size of the embolized device.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported event could not be conclusively determined.A capa was initiated for further investigation on the device embolization per internal procedures.

Event Description

On (b)(6) 2020, a 5-4 amplatzer piccolo was implanted in a 5 kg, 3 month and 30 days old patient using a 4f 80cm amplatzer torqvue lp.The patient has the following pda dimension: minimal diameter: 3.17mm, aortic ampulla (mm) : 6.99mm, pda length (mm) : 4.33mm.The device was placed extraductal on the pulmonary aortic disk side.After implanting the device and waiting for the general anesthesia to wear off, the patient cried hard and wriggled.When the physician checked the transthoracic echocardiogram (tte) for the piccolo, the piccolo was not located where it was implanted.The device had become dislodged and was at the right pulmonary artery.The patient was put under general anesthesia immediately and the piccolo was removed percutaneously with a snare catheter.A 6-4 amplatzer duct occluder was implanted instead and the procedure was completed with no further complications.

• 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: 10229854
• MDR Text Key: 197591654
• Report Number: 2135147-2020-00310
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 05415067031044
• UDI-Public: 05415067031044
• 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,foreig
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-PDAP-05-04-L
• Device Catalogue Number: 9-PDAP-05-04-L
• Device Lot Number: 7308425
• Was Device Available for Evaluation?: No
• 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: 4 MO
• Patient Weight: 5