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 2020-03-27 for MITRACLIP? SYSTEM CLIP DELIVERY SYSTEM CDS0602-XTR manufactured by Abbott Vascular.
[188554855]
The device was not returned for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot. Additionally, a review of the complaint history identified no lot specific product issue. All available information was investigated and the reported migration and slda were determined to be due to challenging patient anatomy. There is no indication of product quality issue with respect to manufacture, design or labeling.
Patient Sequence No: 1, Text Type: N, H10
[188554856]
This is filed to report the single leaflet device attachment (slda). It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with grade 4. The first clip delivery system (cds) was advanced to the mitral valve and the clip was deployed on the medial portion of the valve. However, after removing the gripper line the clip seemed not to be stable and after a while a greater jet appeared. The physician assessed the clip and a single leaflet device attachment (slda) was noted. The clip remained attached to the posterior leaflet only. The physician decided to place a second clip lateral to the first clip in order to stabilize the slda and reduce the lateral jet. After successfully deploying the second clip, the third clip was placed lateral to the second clip to further reduce the lateral jet. To complete the valve treatment, the physician decided to place a fourth clip medial to the first clip to further stabilize the slda and reduce as much as possible mr. Four clips implanted, reducing mr to 2. There was no adverse patient sequela. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-03021 |
| MDR Report Key | 9889421 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-09-24 |
| Date Added to Maude | 2020-03-27 |
| 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 | 2020-03-27 |
| Catalog Number | CDS0602-XTR |
| Lot Number | 90923U165 |
| 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 | 2020-03-27 |