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 2020-03-31 for MITRACLIP? SYSTEM CLIP DELIVERY SYSTEM CDS0602-XTR manufactured by Abbott Vascular.
[187720315]
The device was not returned for analysis. A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that could have contributed to the reported issue. Additionally, a review of the complaint history did not identify any other similar incidents reported from this lot. The reported patient effect of emboli (mitraclip implant) as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures. Based on the available information, the reported poor image resolution and the difficult or delayed positioning (leaflet grasping) were due to challenging patient anatomy. The reported expulsion (ccd/gripper line) was a result of procedural circumstances. The reported difficult to remove was also due to procedural conditions. The reported embolism was a result of procedural conditions as the clip detached and embolized. A definite cause for the reported unintended movement (clip open - locked) could not be determined. There is no indication of product quality issue with respect to manufacture, design or labeling.
Patient Sequence No: 1, Text Type: N, H10
[187720316]
This is filed to report clip embolization. It was reported that this was a mitraclip procedure performed to treat degenerative mitral regurgitation (mr), with an mr grade of 4. Imaging was challenging due to the patient? S scoliosis. The clip was advanced to the mitral valve, grasping was difficult due to the significant scoliosis. During clip deployment, prior to fully releasing the gripper line; the clip opened for a few seconds and the clip detached from both leaflets and embolized. Mr returned to 4. A snare was used to retrieve the clip, a right femoral cut down was performed to remove the clip. No other clips were implanted. The patient is awaiting mitral valve replacement. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-03162 |
| MDR Report Key | 9907893 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2019-07-13 |
| Date Added to Maude | 2020-03-31 |
| 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 | 2020-03-31 |
| Catalog Number | CDS0602-XTR |
| Lot Number | 90713U106 |
| 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. Required No Informationntervention | 2020-03-31 |