MAUDE Adverse Event Report: AGA MEDICAL CORPORATION; AMPLATZER DUCT OCCLUDER II

Model Number 9-PDA2

Device Problem Malposition of Device (2616)

Patient Problems Death (1802); Vasoconstriction (2126); Rupture (2208)

Event Date 09/18/2015

Event Type  Injury  

Manufacturer Narrative

The following three reports are related: adoii -- mdr-2015-20687, this report.7f amplatzer torqvue 180 delivery system -- mdr-2015-19055, follow up report to pending submission.7f ultimum introducer -- mdr-2015-20693, pending submission.The results of the investigation are inconclusive since the adoii was not returned for analysis.A review of the device history record was not possible since the serial number was unavailable.Based on the information received, the cause of the reported incident could not be conclusively determined.Gtin: unknown as adoii lot/serial numbers are unknown.

Event Description

The patient's patent ductus arteriosus was accessed from the aortic side and a 6-6mm amplatzer duct occluder 2 (adoii) was deployed and released.The adoii was found to be protruding into the aorta after release.To facilitate removal of the adoii using a snare, the 5f amplatzer torqvue 180 delivery system (dtv180) was exchanged for a 7f dvt180 in the femoral artery.Through the larger sheath, the adoii was snared and removed without issue.It was reported that prior to removal of an ultimum 7f short femoral sheath, the vessel developed spasms and treatment included the administration of pharmacology agents to stop the spasms.As the ultimum 7f short sheath was removed, a rupture of the iliac artery reportedly occurred and emergency surgery was required.The patient expired secondary to bleeding complications during the hospital stay.The exact cause of death and patient co-morbidities are unknown.The relationship of sjm devices to the need for surgical intervention is unclear.

• Type of Device: AMPLATZER DUCT OCCLUDER II
• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 5163267
• MDR Text Key: 28826608
• Report Number: 2135147-2015-00126
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 09/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Model Number: 9-PDA2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/20/2015
• 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: 6 MO