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 2020-03-30 for MITRACLIP? SYSTEM CLIP DELIVERY SYSTEM CDS0701-NT manufactured by Abbott Vascular.
[188558630]
The other additional 2 mitraclips are being filed under a separate medwatch report number. The device was not returned. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event. A definitive cause for the reported patient effect of tricuspid stenosis and thrombosis could not be determined. It should be noted that the intended use section of the mitraclip system, instruction for use states:? The mitraclip system is intended for reconstruction of the insufficient mitral valve through tissue approximation. The reported off-label use appears to be related to the use of the mitraclip device on the tricuspid valve; however, it could not be determined if using the mitraclip on the tricuspid valve caused or contributed to the reported difficulties. The reported patient effects of tricuspid stenosis and thrombosis are listed in the mitraclip system instructions for use as known possible complications associated with mitraclip procedures. There is no indication of a product quality issue with respect to manufacture, design or labeling.
Patient Sequence No: 1, Text Type: N, H10
[188558631]
This is filed to report thrombosis, stenosis, treatment with medication, and prolonged hospitalization. It was reported that this was a mitraclip procedure to treat functional tricuspid regurgitation (tr) with a grade 4. On (b)(6) 2020, three clips were implanted for off label-use, reducing tr to <1. The next day, imaging revealed thrombosis on the anterior septal region and possibly to the posterior septal region, indicating the thrombosis is across all three clips (00107u222, 91106u225, 91106u244). Additionally, the mean pressure gradient increased to 6mmhg. The stenosis was not treated since the patient did not experience any clinical symptoms. However, blood thinners were administered to the patient in an attempt to treat the thrombosis. The patient will remain hospitalized until the thrombosis is resolved. There was no clinically significant delay in the procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-03095 |
| MDR Report Key | 9898425 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-06 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2019-11-07 |
| Date Added to Maude | 2020-03-30 |
| 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 | 2020-03-30 |
| Model Number | CDS0701-NT |
| Catalog Number | CDS0701-NT |
| Lot Number | 91106U244 |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-03-30 |