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 CDS0602-NTR manufactured by Abbott Vascular.
[188560849]
The additional clip delivery system is filed under a separate medwatch report number. The device was not returned for analysis. A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Based on the information provided the endocarditis is the result of procedure conditions. The reported septic embolism is the result of the endocarditis. The reported fever and infection (meningitis) are the result of the septic embolism. The reported patient effects of fever, embolism, endocarditis, and infection (meningitis), as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures. There is no indication of a product issue with respect to manufacture, design, or labeling.
Patient Sequence No: 1, Text Type: N, H10
[188560850]
This is being filed to report the endocarditis. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3. Two ntr clips were implanted, reducing mr to 1-2. On (b)(6) 2020, the patient was rehospitalized with fever and meningitis related to septic embolism. A transesophageal echocardiography (tee) was performed which showed vegetation on the mitral valve. The patient remains hospitalized and treated with medication. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-03060 |
| MDR Report Key | 9896789 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2019-10-01 |
| 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 |
| Catalog Number | CDS0602-NTR |
| Lot Number | 91001U102 |
| 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 |