MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER MUSCULAR VSD OCCLUDER; CARDIAC OCCLUSION DEVICE

Model Number 9-VSD-MUSC-010

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528)

Patient Problems Embolism (1829); Low Blood Pressure/ Hypotension (1914)

Event Date 06/05/2014

Event Type  Injury  

Event Description

Due to the patient's large patent ductus arteriosus (pda), a 10mm amplatzer muscular vsd occluder (muscvsd) was implanted.After the muscvsd was deployed, a wiggle test and fluoroscopy confirmed satisfactory device placement, so the device was released.The patient was hemodynamically stable and the patient was released to the post-anesthesia recovery unit.Approximately two hours later, the patient's diastolic pressure dropped 30 points and an x-ray determined the muscvsd device had embolized to the right pulmonary artery.Percutaneous retrieval was unsuccessful despite attempts for three hours using various retrieval devices.The patient was referred for surgery where the muscvsd was explanted the same day and pda was surgically repaired.The patient was reportedly stable the next day.

Manufacturer Narrative

The 10mm muscvsd was returned to sjm and decontaminated.The occluder was grossly and microscopically examined, and no anomalies were found.The muscvsd met dimensional specifications when measured with a caliper.The occluder was loaded into a test loader, deployed and retracted without difficulty or deformation, under non-physiological conditions.The device history record for this product was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with sjm specifications and procedures.The results of this investigation confirmed the muscvsd met all functional and dimensional specifications when analyzed at sjm.There was no evidence to suggest there was an intrinsic defect in the occluder, and the cause of the embolization remains unknown.

• Brand Name: AMPLATZER MUSCULAR VSD OCCLUDER
• Type of Device: CARDIAC OCCLUSION DEVICE
• 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 ; 6517565400
• MDR Report Key: 3900450
• MDR Text Key: 4674651
• Report Number: 2135147-2014-00061
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/05/2014

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: Physician
• Device Expiration Date: 01/31/2019
• Device Model Number: 9-VSD-MUSC-010
• Device Lot Number: 4506206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2014
• Initial Date FDA Received: 06/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2014
• 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: 17 YR