MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02 report with the FDA on 2014-07-15 for CRYOVALVE SG- PULMONARY VALVE AND CONDUIT SGPV00 manufactured by Cryolife, Inc..
[4597725]
The patient presented with unacceptable hemodynamics: severe pulmonary insufficiency, chronic chest pain, palpitation, syncope and exercise intolerance. Reoperation/repair on homograft valve. The allograft was implanted on (b)(6) 2002 at (b)(6) for tetralogy of fallot (tof) right ventricular outflow tract (rvot) reconstruction. During a post-op follow up on (b)(6) 2011 an transthoracic echocardiogram was performed and the pulmonary regurgitation was rated as moderate (2+). On the (b)(6) 2011 the insufficiency was found to be sub-valve stenosis and the patient had unacceptable hemodynamics. Additional observations were pulmonary insufficiency, chronic chest pain, palpitation, syncope and exercise intolerance. A reoperation/repair on homograft valve was performed.
Patient Sequence No: 1, Text Type: D, B5
[12129587]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[23566719]
The patient presented with unacceptable hemodynamics: severe pulmonary insufficiency, chronic chest pain, palpitation, syncope, and exercise intolerance. The patient underwent reoperation/repair on the allograft heart valve. The sid number is (b)(4) and the donor number is (b)(6). The allograft was implanted on (b)(6) 2002 at (b)(6) for tetralogy of fallot (tof) right ventricular outflow tract (rvot) reconstruction. During a post-op follow up on (b)(6) 2011 and transthoracic echocardiogram was performed and the pulmonary regurgitation was rated as moderate (2+). Additional observations were pulmonary insufficiency, chronic chest pain, palpitation, syncope, and exercise intolerance. On (b)(6) 2011, the patient had a reoperation on the valve, which is indicated as a melody valve implant for subvalvular stenosis. The cryovalve sg pulmonary valve instructions for use provides adequate listing of adverse events reported with the use of cardiac allografts: calcification, degeneration, and valvular and conduit stenosis. A reoperative procedure for insufficiency and stenosis 9. 5 years after pulmonary valve implant for correction of tof in a (b)(6) patient is not an unexpected outcome.
Patient Sequence No: 1, Text Type: N, H10
[23566720]
The patient presented with unacceptable hemodynamics: severe pulmonary insufficiency, chronic chest pain, palpitation, syncope and exercise intolerance. Reoperation/repair on homograft valve. The allograft was implanted on (b)(6) 2002 at (b)(6) in (b)(6) for tetralogy of fallot (tof) right ventricular outflow tract (rvot) reconstruction. During a post-op follow up on (b)(6) 2011 an transthoracic echocardiogram was performed and the pulmonary regurgitation was rated as moderate (2+). On the (b)(6) 2011 the insufficiency was found to be sub-valve stenosis and the patient had unacceptable hemodynamics. Additional observations were pulmonary insufficiency, chronic chest pain, palpitation, syncope and exercise intolerance. A reoperation/repair on homograft valve was performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2014-00029 |
| MDR Report Key | 3935887 |
| Report Source | 02 |
| Date Received | 2014-07-15 |
| Date of Report | 2014-07-02 |
| Date of Event | 2011-12-21 |
| Date Mfgr Received | 2014-07-02 |
| Date Added to Maude | 2014-07-15 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SANDRA O'REILLY |
| Manufacturer Street | 1655 ROBERTS BLVD., NW |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| Manufacturer Phone | 7704193355 |
| Manufacturer G1 | CRYOLIFE, INC. |
| Manufacturer Street | 1655 ROBERTS BLVD., NW |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30144 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRYOVALVE SG- PULMONARY VALVE AND CONDUIT |
| Generic Name | HEART VALVE ALLOGRAFT |
| Product Code | OHA |
| Date Received | 2014-07-15 |
| Model Number | SGPV00 |
| Lot Number | 7239085 |
| ID Number | DONOR NUMBER: 57390 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRYOLIFE, INC. |
| Manufacturer Address | 1655 ROBERTS BLVD., NW KENNESAW GA 30144 US 30144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-07-15 |