MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER TORQVUE LP CATHETER; CATHETER, PERCUTANEOUS

Model Number 9-TVLPC4F90/080

Device Problem Biocompatibility (2886)

Patient Problem Pericardial Effusion (3271)

Event Date 03/20/2020

Event Type  Injury  

Manufacturer Narrative

The reported event of effusion could not be confirmed.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Reference manufacturing report 2135147-2020-00149 on (b)(6) 2020, a 5-2 amplatzer piccolo was selected for implant in a (b)(6) days old (b)(6) kg baby.The pda has the following dimensions: minimal diameter: 2.63, aortic ampulla: 4.19, length: 9.74.The device placement is intraductal.Pre deployment the device appeared to be in good position.Post deployment it was noted the device shifted toward the pulmonary artery.The device remained stable but was causing some left pulmonary artery stenosis.The device was attempted to be snared, but an effusion was noted.The effusion was drained and the patient was given blood transfusion to maintain hemostability.Another attempt was made to snare the 5-2 device with a 5mm gooseneck, but the device would not recapture into the 4f delivery catheter.The procedure was aborted.The patient is currently stable and the device is in a stable position.The duct is occluded, but there is still left pulmonary artery stenosis, causing some obstruction of flow.The device remains implanted.The patient will be monitored to determine if additional intervention is needed.

• Brand Name: AMPLATZER TORQVUE LP CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9943068
• MDR Text Key: 187117975
• Report Number: 2135147-2020-00150
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-TVLPC4F90/080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2020
• 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
• Treatment: 5-2 AMPLATZER PICCOLO OCCLUDER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 41 DA
• Patient Weight: 1