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U.S. Department of Health and Human Services

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

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ABBOTT MEDICAL AMPLATZER PICCOLO OCCLUDER; OCCLUDER, PATENT DUCTUS, ARTERIOSUS Back to Search Results
Model Number 9-PDAP-04-02-L
Device Problems Migration or Expulsion of Device (1395); Obstruction of Flow (2423)
Patient Problems Pulmonary Dysfunction (2019); Renal Failure (2041); Obstruction/Occlusion (2422); Foreign Body Embolism (4439)
Event Date 05/11/2021
Event Type  Injury  
Manufacturer Narrative
The results, method, and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
It was reported that on (b)(6) 2021, a 4/2 amplatzer piccolo occluder was selected for implant in a (b)(6) day old (b)(6) kg patient that was critically ill with respiratory failure and renal insufficiency.The patient had the following patent ductus arteriosus (pda) dimensions: pda minimal diameter of 2.4mm, pda length of 8.2mm and diameter at aortic ampulla of 3.3mm.During the procedure the device was successfully placed intraductally near the aortic end of the pda without impingement on the pulmonary artery (pa) or aorta.5 days post implant, the patient presented with symptomatic aortic obstruction, left ventricle (lv) dysfunction, and renal failure.The patient was taken back to the cath lab and it was found that the device had migrated such that the aortic disc and part of central disc were pushing into aorta, not allowing for the use of a stent.The device couldn't be removed or coarctation stented by transcatheter approach, so device was removed surgically.The pda was ligated and the aorta repaired.No residual pda or coarctation was noted by echo post pda device removal.The patient is recovering but is critically ill, as they were prior to the procedure.No additional information was provided.
 
Manufacturer Narrative
An event of migration of device was reported.A more comprehensive assessment could not be performed, as the device was not returned for analysis.The device history record was reviewed, to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.A capa was initiated for further investigation into complaints regarding embolization and migration of piccolo occluder, per internal procedures.
 
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Brand Name
AMPLATZER PICCOLO OCCLUDER
Type of Device
OCCLUDER, PATENT DUCTUS, ARTERIOSUS
Manufacturer (Section D)
ABBOTT MEDICAL
5050 nathan lane north
plymouth MN 55442
MDR Report Key12013548
MDR Text Key256717263
Report Number2135147-2021-00245
Device Sequence Number1
Product Code MAE
UDI-Device Identifier05415067031006
UDI-Public05415067031006
Combination Product (y/n)N
PMA/PMN Number
P020024
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/06/2021
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
Device Operator Health Professional
Device Model Number9-PDAP-04-02-L
Device Catalogue Number9-PDAP-04-02-L
Device Lot Number7710451
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/18/2021
Initial Date FDA Received06/16/2021
Supplement Dates Manufacturer Received07/19/2021
Supplement Dates FDA Received08/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
Patient Age27 DA
Patient Weight1
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