MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-26 for MITRACLIP? SYSTEM CLIP DELIVERY SYSTEM CDS0601-XTR manufactured by Abbott Vascular.
[185230488]
All available information was investigated and the reported unintended movement and difficult to open or close could not be confirmed during return device analysis as the device functioned normally. A review of the lot history record revealed no manufacturing nonconformities to the reported lot that would have resulted in the event. Additionally, a review of the complaint history identified no other complaints reported from this lot. It should be noted the instructions for use (ifu) of the mitraclip system states,? Do not use mitraclip? Outside of the labeled indication?. Based on this information, the reported off-label use of the device appears to be due to user error. However, the off-label use did not likely contribute to the reported issues. There is no indication of product quality issue with respect to manufacture, design or labeling.
Patient Sequence No: 1, Text Type: N, H10
[185230489]
This is filed to report the clip opening during the procedure. It was reported that this was a mitraclip procedure, used off label to treat grade 4 mixed etiology tricuspid regurgitation (mr). The tricuspid leaflets were grasped. Before the clip was deployed, the final arm angle was checked, but the clip failed, it opened during the test. Troubleshooting was performed and final arm angle was checked a second time, but it was the same outcome. Troubleshooting was performed again and the clip was unable to close past 60 degrees. At this point, it was decided to remove and replace this device. The grippers were raised, the clip was inverted, and the clip was then able to close all the way. The clip was removed without incident. Another mitraclip was used to complete the procedure. One mitraclip was implanted reducing tr to grade 2. There were no adverse patient effects and no clinically significant delay in the procedure. There was no additional information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02981 |
| MDR Report Key | 9885421 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2019-11-14 |
| Date Added to Maude | 2020-03-26 |
| 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 | MITRACLIP? SYSTEM CLIP DELIVERY SYSTEM |
| Generic Name | VALVE REPAIR |
| Product Code | NKM |
| Date Received | 2020-03-26 |
| Returned To Mfg | 2020-03-12 |
| Model Number | CDS0601-XTR |
| Catalog Number | CDS0601-XTR |
| Lot Number | 91114U124 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-26 |