Definition: Provides Fixation And Sealing Between And Endovascular Graft And The Native Artery.
| Device Type ID | 955 |
| Device Name | Endovascular Suturing System |
| Physical State | The System Is Comprised Of The Implant Device And An Endovascular Delivery Device Used To Implant The Endovascular Suture. |
| Technical Method | Uses A Metallic Implant, Delivered Through A Catheter-based System, To Affix The Material Of An Endovascular Graft To Native Vessel |
| Target Area | The Implant Is To Be Placed At The Proximal End Of An Aortic Aneurysm. |
| Regulation Description | Endovascular Suturing System. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Diagnostics Devices Branch (CDDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.3460 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OTD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 955 |
| Device | Endovascular Suturing System |
| Product Code | OTD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endovascular Suturing System. |
| CFR Regulation Number | 870.3460 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
APTUS ENDOSYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC VASCULAR, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 213 |
Leak / Splash | 184 |
Break | 38 |
Device Dislodged Or Dislocated | 37 |
Device Damaged By Another Device | 16 |
Device Difficult To Setup Or Prepare | 13 |
Activation, Positioning Or Separation Problem | 11 |
Malposition Of Device | 11 |
Difficult To Insert | 7 |
Fracture | 7 |
Device Operates Differently Than Expected | 7 |
Material Deformation | 6 |
Positioning Problem | 5 |
Difficult To Remove | 5 |
Packaging Problem | 3 |
Kinked | 2 |
Occlusion Within Device | 2 |
Misfire | 1 |
Device Displays Incorrect Message | 1 |
Delivered As Unsterile Product | 1 |
Material Twisted / Bent | 1 |
Failure To Adhere Or Bond | 1 |
Compatibility Problem | 1 |
Inability To Irrigate | 1 |
Device Markings / Labelling Problem | 1 |
Device Expiration Issue | 1 |
Difficult To Position | 1 |
Detachment Of Device Component | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Air Leak | 1 |
Failure To Power Up | 1 |
| Total Device Problems | 581 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Medtronic Vascular, Inc. | II | Sep-27-2017 |