MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-11 for GORE VIABAHN? ENDOPROSTHESIS - 3 JHJR051002J manufactured by W.l. Gore & Associates.
[187923555]
(b)(4). The device was returned to w. L. Gore & associates for investigation. The following observations were made: the delivery catheter, deployment knob, and deployment line were returned. The deployment line was returned in two sections and appeared to be broken. One section was still attached to the deployment knob and measured 150cm including a 1. 2cm single fiber on the end. Approximately 37. 7cm and 141. 3cm from the deployment knob, there were two knots in this section of deployment line. The second section measured approximately 82. 5cm including two single fibers on one end measuring 59. 2cm and 70. 7cm. There was a knot in the single fibers approximately 47. 1cm from the end. The remainder of the device appeared unremarkable. Based on the device evaluation performed, no manufacturing anomalies were identified to which the event could be definitively attributed. Engineering evaluation conclusion is inconclusive as it relates to the event description. The reported issue codes are representative of this event. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[187923556]
On (b)(6) 2020, the patient underwent an endovascular treatment for thoracic aortic dissection using gore? Tag? Conformable thoracic stent graft with active control system (ctag-ac), gore? Excluder? Aaa endoprosthesis, and gore? Viabahn? Endoprosthesis with heparin bioactive surface (viabahn). The ctag-ac was reportedly placed below the left subclavian artery. Next the gore? Excluder? Aaa endoprosthesis was inserted into the abdominal aorta and a viabahn was inserted into the left renal artery. It was reported during deployment the viabahn deployed approximately 2cm and resistance was encountered. The physician reportedly continued pulling the deployment line with strong force. It was reported the deployment line broke and became separated from the device. The physicians suspected cause of the deployment line breaking is unknown. It was noted that the viabahn was not fully expanded with approximately 2cm of the stent graft un-deployed. A balloon catheter was inserted and inflated to fully expand the device. It was reportedly noted that the deployment line still attached to the delivery catheter was about 60cm in length. The procedure was completed. The patient tolerated the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017233-2020-00087 |
| MDR Report Key | 9694938 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-11 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-01-22 |
| Device Manufacturer Date | 2018-12-11 |
| Date Added to Maude | 2020-02-11 |
| 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 | MARCOS AYALA |
| Manufacturer Street | 1500 N. 4TH STREET |
| Manufacturer City | AZ |
| Manufacturer Phone | 9285263030 |
| Manufacturer G1 | MEDICAL ECHO RIDGE B/P |
| Manufacturer Street | 3250 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 VIABAHN? ENDOPROSTHESIS - 3 |
| Generic Name | NIP |
| Product Code | PFV |
| Date Received | 2020-02-11 |
| Returned To Mfg | 2020-01-28 |
| Catalog Number | JHJR051002J |
| Lot Number | 20175973 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-02-11 |