MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-27 for CDS07 CDS0701-NTW manufactured by Abbott Vascular.
[188556282]
The device was not returned for analysis as the mitraclip remains in the patient. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event. Additionally, a review of the complaint did not indicate a lot-specific product issue. All information was investigated and the difficult positioning (difficulty grasping the leaflets) appears to be related to patient morphology/pathology. The cause for the reported partial clip movement could not be determined. There is no indication of a product issue with respect to manufacture, design or labeling. The first undeployed mitraclip ntw and the steerable guide catheter are filed under separate medwatch report numbers.
Patient Sequence No: 1, Text Type: N, H10
[188556283]
This is filed to report the clip movement after deployment. It was reported that this was a mitraclip procedure in the patient with p2/3 flail and grade 4 degenerative mitral regurgitation (mr). The first mitraclip ntw was advanced and the grippers were checked, but only one of the grippers was responding to the gripper lever. This first ntw was removed from the patient, undeployed. Another mitraclip ntw was inserted and had difficulty grasping. Although the leaflet was not in the apex of the mitraclip, it was thought that there was enough leaflet insertion that all the gripper fixation elements were on leaflet tissue by way of measuring leaflet pre and post clip closure. The physician thought this should be stable enough to place another lateral clip to ensure a durable result. After deployment, the clip shifted and lost some of the posterior leaflet, but remained on both mitral valve leaflets. A second mitraclip, an nt, was implanted medial to the ntw clip, but it did not stabilize the first clip. A third mitraclip, another nt, was implanted lateral to the first mitraclip. Mr was reduced to grade 1-2. Right to left flow was noted and the oxygen saturation dropped into the low 80s. An atrial septal occluder was implanted which stopped the flow reversal (right to left) and subsequently, the oxygen saturation improved and returned to 100%. The procedure continued with the implantation of two mitraclip ntws on the tricuspid valve reducing tricuspid regurgitation to grade 1. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-03013 |
| MDR Report Key | 9890756 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-11 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2019-11-09 |
| Date Added to Maude | 2020-03-27 |
| 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 | MS. LINDSEY BELL |
| Manufacturer Street | 26531 YNEZ RD. |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal | 925914628 |
| Manufacturer Phone | 9519143996 |
| Manufacturer G1 | ABBOTT VASCULAR, REG # 3005070406 |
| Manufacturer Street | 3885 BOHANNON DRIVE |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94025 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CDS07 |
| Generic Name | VALVE REPAIR |
| Product Code | NKM |
| Date Received | 2020-03-27 |
| Model Number | CDS0701-NTW |
| Catalog Number | CDS0701-NTW |
| Lot Number | 91109U190 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT VASCULAR |
| Manufacturer Address | 26531 YNEZ RD. TEMECULA CA 925914628 US 925914628 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-27 |