MAUDE Adverse Event Report: AGA MEDICAL CORPORATION DELIVERY SYSTEM ITV 7F 180/80 US

Model Number 9-ITV07F180/80

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Embolism (1829); Hemorrhage/Bleeding (1888); Ischemia (1942); Laceration(s) (1946); Patient Problem/Medical Problem (2688)

Event Date 06/23/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The patient experienced an embolization of an amplatzer duct occluder (ado) 24 hours post implant which required a repeat catheterization for retrieval.The patient experienced hemodynamically significant bleeding in the retroperitoneal space which required surgical evacuation.The patient was found to have a laceration of the iliac artery related to the 7f amplatzer torqvue 180 delivery system (dtv180) that was used for the ado retrieval.The patient developed left foot ischemia which required amputation secondary to the vascular injury.Please reference mdr# 2135147-2015-00137 for the ado.

Manufacturer Narrative

(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

The patient experienced an embolization of a 5/4 mm amplatzer duct occluder (ado) 24 hours post implant which required a repeat catheterization for retrieval.The patient experienced hemodynamically significant bleeding in the retroperitoneal space which required surgical evacuation.The patient was found to have a laceration of the iliac artery related to the 7f amplater torqvue 180 delivery system (dtv180) that was used for the ado retrieval.The patient developed left foot ischemia which required amputation secondary to the vascular injury.

• Brand Name: DELIVERY SYSTEM ITV 7F 180/80 US
• Type of Device: DELIVERY SYSTEM
• 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: 5219964
• MDR Text Key: 31000856
• Report Number: 2135147-2015-00136
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Model Number: 9-ITV07F180/80
• Device Catalogue Number: 9-ITV07F180/80
• Device Lot Number: 4314493
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2013
• 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): Hospitalization; Required Intervention; Disability