MAUDE Adverse Event Report: ST JUDE MEDICAL INC - AN ABBOTT LAB / ST. JUDE MEDICAL COSTA RICA LTDA. OCCLUDER PICCOLO 5MM 4MM; OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Model Number 9-PDAP-05-04-L

Device Problem Obstruction of Flow (2423)

Patient Problem Renal Failure (2041)

Event Date 04/11/2023

Event Type  Death  

Event Description

Migration of piccolo device causing severe descending aortic obstruction.A pre-term infant with a large sunt from a pda went to the cath lab on (b)(6) 2023 for placement of a piccolo device.The duct measured 3.8 mm in diameter on the aortic end and 2.3 mm on the pa end, with a length of 8.7 mm.A 5-4 piccolo device was placed without incident.The echocardiogram showed no significant aortic or lpa obstruction.Follow-up echo on 4/8/2023 showed the device in stable position with no flow acceleration in the aorta.The patient began to decompensate late the night of (b)(6) 2023 and an echocardiogram was ordered on (b)(6) 2023.This showed severe obstruction to the descending aorta.The patient was taken emergently to the cath lab at this time and the original piccolo device was snared and removed from the body without difficulty.A 4-4 piccolo device was then placed without incident.Follow-up echocardiogram that evening and all subsequent studies (4/13, 4/18, 4/23 and 4/24) showed the device in stable position with no obstruction to the aorta or lpa.The patient suffered renal failure and support was withdrawn on (b)(6) 2023.

• Brand Name: OCCLUDER PICCOLO 5MM 4MM
• Type of Device: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): ST JUDE MEDICAL INC - AN ABBOTT LAB / ST. JUDE MEDICAL COSTA RICA LTDA.; plymouth MN 55442
• MDR Report Key: 16886167
• MDR Text Key: 314737585
• Report Number: MW5117280
• Device Sequence Number: 1
• Product Code: MAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9-PDAP-05-04-L
• Device Lot Number: 8410047
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Death; Disability
• Patient Age: 28 DA
• Patient Sex: Male
• Patient Weight: 1 KG
• Patient Ethnicity: Hispanic