MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-03 for GORE? CARDIOFORM SEPTAL OCCLUDER GSX0030A manufactured by W.l. Gore & Associates.
[188139652]
The gore? Cardioform septal occluder instructions for use list perforation or damage of a cardiovascular structure by the device as a potential device-or procedure-related adverse event.
Patient Sequence No: 1, Text Type: N, H10
[188139653]
It was reported the physician selected a 30mm gore? Cardioform septal occluder to close a patent foramen ovale (pfo) with an 11mm tunnel. The physician deployed the left atrial disc three times in the pfo tunnel. In each case, the delivery system was not visualized on intracardiac echocardiography (ice) prior to deployment. During the third attempt of deploying the left atrial disc the proctoring physician noted an effusion on ice. The patient had an increased heart rate and was unresponsive. The device was removed and the medical team started emergency procedures. The patient was intubated and pericardiocentesis was performed. The patient stabilized following pericardiocentesis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017233-2020-00139 |
| MDR Report Key | 9779748 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-03 |
| Date of Report | 2020-02-14 |
| Date of Event | 2020-02-14 |
| Device Manufacturer Date | 2019-12-28 |
| Date Added to Maude | 2020-03-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MARCI STEWART |
| Manufacturer Street | 1500 N. 4TH STREET |
| Manufacturer City | FLAGSTAFF AZ |
| Manufacturer Phone | 9285263030 |
| Manufacturer G1 | KENDRICK PEAK MPD B/P |
| Manufacturer Street | 4250 W. KILTIE LANE |
| Manufacturer City | FLAGSTAFF AZ 86005 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 86005 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GORE? CARDIOFORM SEPTAL OCCLUDER |
| Generic Name | TRANSCATHETER, SEPTAL OCCLUDER |
| Product Code | MLV |
| Date Received | 2020-03-03 |
| Model Number | GSX0030A |
| Catalog Number | GSX0030A |
| Lot Number | 21506185 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | W.L. GORE & ASSOCIATES |
| Manufacturer Address | FLAGSTAFF AZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-03 |