MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2020-03-30 for MITRACLIP? SYSTEM CLIP DELIVERY SYSTEM UNK CDS manufactured by Abbott Vascular.
[188561104]
Event dates estimated. The device was not returned for analysis. A review of the lot history record could not be performed due to unknown lot information. The reported patient effects of inflammation and mitral regurgitation as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures. Based on the information reviewed, a conclusive cause for the reported patient effects cannot be determined. There is no indication of a product issue with respect to manufacture, design, or labeling. Literature attached: mitral valve surgery after mitraclip implantation: what histopathology can tell us? No additional information was provided.
Patient Sequence No: 1, Text Type: N, H10
[188561105]
This is being filed to report the recurrent mr and inflammation requiring surgical intervention. It was reported through a research article identifying mitraclip that maybe related to the following: mitral regurgitation, inflammation, surgical procedure, and hospitalization. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr). Two clips were implanted with good post-interventional results. One year post implant, severe residual mr was noted therefore the patient was sent for surgical removal of the mitraclips devices. Upon examination, the mitraclip devices were intact however significant inflammatory reactions were seen in the surrounding tissue. Details are listed in the attached article titled: mitral valve surgery after mitraclip implantation: what histopathology can tell us? No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-03063 |
| MDR Report Key | 9897006 |
| Report Source | LITERATURE |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-01 |
| Date Mfgr Received | 2020-03-10 |
| 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 | UNK CDS |
| 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; 3. Deathisabilit | 2020-03-30 |