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-NTR manufactured by Abbott Vascular.
[188402307]
The device was received. The investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
Patient Sequence No: 1, Text Type: N, H10
[188402308]
This is being filed to report the premature deployment and difficulty removing the device requiring surgical intervention. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4. One clip was successfully implanted. A second clip delivery system (cds) was advanced to the mitral valve however the mr was unable to be reduced further. The leaflets were ungrasped and the clip repositioned several times however the mr was unable to be reduced. The cds was retracted per the instructions for use (ifu) however the clip became caught on the tip of the steerable guide catheter (sgc). Standard troubleshooting was performed; however the clip could still not be retracted. The system was pulled back to the right side and pulled through the septum without issue. It was noted the clip looked like it had detached from the mandrel even though no deployment had been initiated. The sgc and cds were retracted to the groin where it was noted one clip arm was inside the sgc and one clip arm was stuck on the vessel wall. A vascular surgeon was called to perform a cut down. Once removed, it was confirmed the clip was no longer attached to the mandrel but was still attached to the cds by the lock and gripper lines. The procedure was completed at this time with the mr reduced to 3. There was no clinically significant delay in the procedure and no adverse patient sequela. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02968 |
| MDR Report Key | 9885019 |
| 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 | 2019-11-20 |
| 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 | 2020-03-16 |
| Model Number | CDS0601-NTR |
| Catalog Number | CDS0601-NTR |
| Lot Number | 91119U185 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-26 |