MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES, INC. GORE CARDIOFORM ASD OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number ASD37A

Device Problems Difficult to Remove (1528); Deformation Due to Compressive Stress (2889); Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 01/29/2021

Event Type  malfunction  

Event Description

Under tee (transesophageal echocardiogram) and fluoroscopic guidance the asd (atrial septal defect) was balloon sized with a 24 mm aga sizing balloon ii with a stretched diameter of 20 mm.Initially a 37 mm gore cardioform asd occluder was used to try to occlude the asd.Tee monitoring showed the device in appropriate position and the decision was made to lock the device.Immediately after the device was locked, it embolized into the right atrium being still attached to its retrieval cord.At this point the delivery catheter was unscrew from its retrieval luer and advanced to the right eyelet of the device and the handle of the device was retracted to recapture the device inside the delivery catheter.Unfortunately, during this maneuver, the delivery catheter kinked between the tip and the guidewire slot located at the distal end of the delivery catheter making impossible to retrieve the device.At this point a second venous access was established in the left femoral vein and a 20 fr dryseal introducer was advanced from this access into the right atrium.The left eyelet of the device was then snared from the left venous access and the device was pulled inside the 20 fr dryseal and eventually retrieve outside the patient body, after having cut the retrieval cord still attached to the handle of the device.The patient had another manufacturer's asd occluder device was successfully placed.Patient did well, remained overnight per plan and discharged the following day.

• Brand Name: GORE CARDIOFORM ASD OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES, INC.; 301 airport rd; elkton MD 21921
• MDR Report Key: 11306821
• MDR Text Key: 231140565
• Report Number: 11306821
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ASD37A
• Device Catalogue Number: ASD37A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/04/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21170 DA
• Patient Weight: 68