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

Catalog Number UNK AMPLATZER PICCOLO

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Insufficient Information (4580)

Event Date 08/26/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6) 2022, an unknown size amplatzer piccolo occluder was selected for implant.During device release it embolized into the patient's left pulmonary artery.No patient consequences were reported.

Manufacturer Narrative

An event of device embolization was reported.A returned device assessment could not be performed as the device and was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined, however is consistent with device being too small.H6 device code 4648 removed.

Event Description

Subsequent to the previously filed report, additional information was received that the amplatzer piccolo occluder was snared.It was noted via transesophageal echocardiogram that the occluder had embolized immediately after release from the delivery cable.The delivery system used to implant the amplatzer piccoo occluder was an unknown size amplatzer torqvue lp delivery system.There was no clinically significant delay in the implant procedure reported.The patient was stable at the time of report.There was no allegation of malfunction against the amplatzer piccolo occluder or procedure.The cause of the amplatzer piccolo occluder embolizing was due to the occluder being too small.No additional information was provided.

• Brand Name: AMPLATZER PICCOLO
• Type of Device: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15457714
• MDR Text Key: 300268284
• Report Number: 2135147-2022-01271
• Device Sequence Number: 1
• Product Code: MAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2022

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK AMPLATZER PICCOLO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2022
• Initial Date FDA Received: 09/20/2022
• Supplement Dates Manufacturer Received: 12/06/2022
• Supplement Dates FDA Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Other