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.
[186764426]
The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information.
Patient Sequence No: 1, Text Type: N, H10
[186764427]
This is filed to report during the procedure, the clip delivery system (cds) had bubbles that could not be eliminated from the delivery handle. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with grade of 3-4. The clip delivery system (cds) was advanced to the mitral valve but bubbles were noted in the delivery catheter handle. Aspiration attempts to eliminate the air bubbles let to more bubbles. There was no air introduced into the patient. The cds was removed without issue. Two clips were implanted reducing mr to <1. There was no adverse patient effect and no clinically significant delay in the procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-03062 |
| MDR Report Key | 9896855 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2019-10-21 |
| 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 |
| Returned To Mfg | 2020-03-25 |
| Catalog Number | CDS0602-NTR |
| Lot Number | 91019U118 |
| 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 | 2020-03-30 |