MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-06 for MITRACLIP G4 STEERABLE GUIDE CATHETER SGC0701 manufactured by Abbott Vascular.
[182599536]
The device was not returned for evaluation. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. The reported patient effect of cardiac perforation (atrial perforation) as listed in the mitraclip system instructions for use is a known possible complication associated with mitraclip procedures. Based on the information reviewed it appears that user technique/procedural circumstances likely influenced the atrial perforation. There is no indication of a product quality issue with respect to manufacture, design or labeling. The clip delivery system is filed under a separate medwatch report number.
Patient Sequence No: 1, Text Type: N, H10
[182599537]
This is filed for atrial septal defect (asd), requiring intervention. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4. It was noted that the mitral valve seemed to have a larger than expected number of chords, which were noted to be wider and thicker than normal, as well as fragile leaflets. The clip delivery system (cds) was advanced to the leaflets. Difficulty was noted grasping the leaflets, and the clip became caught in the chords multiple times. The clip was removed from the chords; however, it was suspected that a chordal rupture occurred, as the mr increased to grade 4+. The cds, including the clip and the steerable guide catheter (sgc) were removed without issue. The decision was made to implant an atrial septal defect (asd) occluder, as mr was not reduced and the patient had a history of right heart failure. Post procedure, the patient was in stable condition. No additional intervention was performed. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02106 |
| MDR Report Key | 9802446 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-02-11 |
| Date Mfgr Received | 2020-02-11 |
| Device Manufacturer Date | 2019-10-23 |
| Date Added to Maude | 2020-03-06 |
| 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 G4 STEERABLE GUIDE CATHETER |
| Generic Name | CATHETER, STEERABLE |
| Product Code | DRA |
| Date Received | 2020-03-06 |
| Model Number | SGC0701 |
| Catalog Number | SGC0701 |
| Lot Number | 91022U106 |
| 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 | 2020-03-06 |