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

Model Number Duct Occluder

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypoxia (1918); Pulmonary Edema (2020)

Event Type  Injury  

Manufacturer Narrative

An event of decrease in blood pressure and sp02 when the sheath was placed was reported through a literature article.A pulmonary hypertension crisis was suspected and residual pulmonary hypertension was noticed immediately after the procedure, however improvement was noted during follow-up.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or additional patient information was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

The article, ¿a case of asd, pda, ph, t risomy2 l treated with percutaneous ductus arteriosus closure at 1 month of age¿, was reviewed.The research article presents a case study of percutaneous ductus arteriosus closure in infants, particularly those weighing less than 6kg, has been reported to have more adverse events than that.In this case, a (b)(6), 3680g had a history of atrial septal defect (asd), patent ductus arteriosus (pda), pulmonary hypertension (ph) , trisomy21.Percutaneous ductus arteriosus closure was planned, echocardiogram showed a pda diameter of 3.1mm and a relatively high pda shunt volume, and cardiomegaly and pulmonary hypertension were observed.Krichenko type a showed a ductus arteriosus minimal diameter of 2.1mm, maximal diameter of 9.0mm, central diameter of 3.0mm, ductus arteriosus length of 6.0mm, pulmonary flow/systemic flow (qp/qs) =2.9, pulmonary/systemic arterial pressure (pp/ps) =0.9.Amplatzer duct occluder (ado) 8-6mm was selected.During the procedure, a decrease in blood pressure and a decrease in sp02 were observed when the long sheath advanced to the descending aorta.There was no decrease in heart rate.Ph crisis was suspected, and oxygenation, vasopressor administration and volume-loading were performed, and the blood pressure and sp02 recovered promptly.Subsequently, ado placement was performed, and the patient's vitals finished the operation in a stable condition.Though the residual pulmonary hypertension was observed immediately after the operation, the ductus arteriosus was completely closed and hot was introduced, and the asd was narrowed during the follow-up, and the improvement of pulmonary hypertension has been observed.Conclusion: we experienced a case of suspected ph crisis due to temporary decrease in blood pressure during the procedure of percutaneous ductus arteriosus closure combined with increased pulmonary blood flow and pulmonary hypertension in early infancy.Recently, the wide range of device selection has expanded, and in cases such as low body weight and combined pulmonary hypertension, it seems to be easy to obtain the circulatory stability in the operation by using the less invasive delivery system.Considering the possibility of ph crisis, it seemed to be important to plan the treatment including device selection and countermeasures in case of the occurrence, etc.After considering the invasiveness.The article concluded that suspected ph crisis due to temporary decrease in blood pressure during the procedure of percutaneous ductus arteriosus closure combined with increased pulmonary blood flow and pulmonary hypertension in early infancy.Recently, the wide range of device selection has expanded, and in cases such as low body weight and combined pulmonary hypertension, it seems to be easy to obtain the circulatory stability in the operation by using the less invasive delivery system.Considering the possibility of ph crisis, it seemed to be important to plan the treatment including device selection and countermeasures in case of the occurrence, etc.After considering the invasiveness.The author and corresponding author of this article is sachiko inukai md, japan, 466-8650 aichi, nagoya, showa ward, myokencho, 2-9.

• Brand Name: AMPLATZER DUCT OCCLUDER
• Type of Device: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 14519001
• MDR Text Key: 293283048
• Report Number: 2135147-2022-00325
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 00811806011127
• UDI-Public: 00811806011127
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: Duct Occluder
• Device Catalogue Number: 9-PDA-005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2022
• 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
• Patient Age: 1 MO