MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2020-03-19 for RING TRI-AD 900SFC26 manufactured by Medtronic Heart Valves Division.
[184174299]
Citation: jung w et al. Early clinical outcomes of tricuspid valve repair with a tri-ad annuloplasty ring in comparison with the outcomes using an mc3 ring. Korean j thorac cardiovasc surg. 2018 apr;51(2):92-99. Doi: 10. 5090/kjtcs. 2018. 51. 2. 92. Epub 2018 apr 5. Earliest date of publish used for event date and death date. No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported. Without return of the product no definitive conclusion can be made regarding the clinical observations. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184174300]
Medtronic received information via literature regarding a comparison of the early outcomes in patients who underwent tricuspid valve annuloplasty with a tri-ad ring or an mc3 ring. All data were retrospectively collected from a single center between january 2007 and march 2017. The study population included 229 patients and was predominantly male with a mean age of 59 years. Of those, 36 were implanted with medtronic tri-ad annuloplasty rings. No serial numbers were provided. Among all tri-ad patients, one operative death occurred due to unidentified bleeding and hypovolemic shock. Based on the available information, medtronic product may have been associated with the death. Among all tri-ad patients, adverse events included: reoperation due to bleeding, low cardiac output syndrome, stroke, atrial fibrillation, moderate-severe pulmonary hypertension, mild-moderate-severe tricuspid regurgitation, and moderate-severe left ventricle dysfunction (left ventricular ejection fraction less than 40%). Based on the available information, medtronic product was associated with the adverse events. No additional adverse patient effects or product performance issues were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025587-2020-00864 |
| MDR Report Key | 9856621 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2018-04-05 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2020-03-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PAULA BIXBY |
| Manufacturer Street | 8200 CORAL SEA STREET NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635055378 |
| Manufacturer G1 | MEDTRONIC HEART VALVES DIVISION |
| Manufacturer Street | 1851 E DEERE AVE |
| Manufacturer City | SANTA ANA CA 92705 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92705 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RING TRI-AD 900SFC26 |
| Generic Name | RING, ANNULOPLASTY |
| Product Code | KRH |
| Date Received | 2020-03-19 |
| Model Number | 900SFC26 |
| Catalog Number | 900SFC26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC HEART VALVES DIVISION |
| Manufacturer Address | 1851 E DEERE AVE SANTA ANA CA 92705 US 92705 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-03-19 |