MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2020-03-31 for MITRACLIP? SYSTEM CLIP DELIVERY SYSTEM UNK CDS manufactured by Abbott Vascular.
[188868673]
Date of event, implant date: estimated dates. The devices are reported from an article; and therefore, will not be requested for return. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The other patient effect reported will be filed under a separate medwatch. (b)(4). Literature: outcomes of ttvi in patients with pacemaker or defibrillator leads data from the trivalve registry.? (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188868674]
This is filed to report pericardial effusion, renal failure,heart failure, cerebrovascular, myocardial infarction, atrial fibrillation, sepsis, prolonged hospitalization, worsening and recurrent tricuspid regurgitation. It was reported through a research article identifying mitraclip devices that may be related to the following: death, pericardial effusion, renal failure,heart failure, cerebrovascular, myocardial infarction, atrial fibrillation, sepsis, prolonged hospitalization, worsening and recurrent tricuspid regurgitation. Specific patient information is documented as unknown. Details are listed in the article, titled outcomes of ttvi in patients with pacemaker or defibrillator leads data from the trivalve registry.?
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-03143 |
| MDR Report Key | 9904611 |
| Report Source | LITERATURE |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2015-01-01 |
| Date Mfgr Received | 2020-03-10 |
| 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 | 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. Deathisabilit | 2020-03-31 |