MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,litera report with the FDA on 2015-09-23 for VASCU-GUARD VG0108N manufactured by Synovis Surgical Innovations.
[26588715]
(b)(4). Initial reporter facility name: (b)(6). Literature article: moon, r. C. , teixeira, a. F. , jawad, m. A. Treatment of weight regain following roux-en-y gastric bypass: revision of pouch, creation of new gastrojejunostomy and placement of proximal pericardial patch ring. Obesity surgery 24 (6) (pp 829-834), jan. 2014 should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[26588716]
It was reported that a patient experienced nausea, vomiting, and dysphagia coincident with a roux-en-y gastric bypass surgery in which vascu-guard was used. The patient experienced the nausea and vomiting 40 days post-surgery and was readmitted to the hospital. 9 months post-surgery, the patient experienced dysphagia and was again readmitted to the hospital and had an operation for the removal of the vascu-guard patch and revision of gastrojejunostomy anastomosis. Patient outcome was not reported. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[28307682]
(b)(4). The event occurred sometime between december 2009 and april 2013. The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2015-36985 |
| MDR Report Key | 5098733 |
| Report Source | COMPANY REPRESENTATIVE,LITERA |
| Date Received | 2015-09-23 |
| Date of Report | 2015-10-14 |
| Date Mfgr Received | 2015-10-09 |
| Date Added to Maude | 2015-09-23 |
| 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 | KINGA ALMASAN |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 2242702068 |
| Manufacturer G1 | SYNOVIS SURGICAL INNOVATIONS |
| Manufacturer Street | 2575 UNIVERSITY AVE. W |
| Manufacturer City | SAINT PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55144 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VASCU-GUARD |
| Generic Name | PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE |
| Product Code | DKZ |
| Date Received | 2015-09-23 |
| Catalog Number | VG0108N |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNOVIS SURGICAL INNOVATIONS |
| Manufacturer Address | 2575 UNIVERSITY AVE. W SAINT PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2015-09-23 |