MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2014-11-19 for CRYOVALVE SG - PULMONARY VALVE AND CONDUIT SGPV00 manufactured by Cryolife, Inc..
[5003767]
Complainant offered feedback that they have identified at least two instances of cryolife sg pulmonary valves becoming stenotic quicker than they would have expected or have seen in their past experience.
Patient Sequence No: 1, Text Type: D, B5
[12577427]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[37763303]
According to the a0 form (b)(6), the chief perfusionist at (b)(6) hospital, offered feedback that the hospital have identified at least two instances of cryolife synergraft pulmonary valves (sgpv) becoming stenotic quicker than they would have expected or have seen in their past experience. Additional information from the complainant (b)(6), confirmed that it was in fact one sgpv which became "stenotic quicker than they would have expected" not two. (b)(6) provided cryolife with the following additional information on (b)(6)2014. The sgpv was implanted on (b)(6) 2013. The patient presented with symptoms of fatigue (b)(6) 2014). A catheterization was done on (b)(6) 2014 and it was determined that the sgpv was stenotic. Surgery to replace the conduit was performed on (b)(6) 2014 and a 20 mm contegra was used. The following additional information was requested and received from (b)(6) on (b)(6) 2014. The patient had a tetralogy of fallot (tof) pulmonary atresia with confluent pulmonary arteries, right aortic arch with mirror- image branching. On (b)(6) 1994 the patient had 3. 5mm aorta-to-main pulmonary artery gore-tex shunt placed. The tof was repaired with a patch closure of ventricular septal defect central shunt take down, 1. 5mm right ventricle-to-pulmonary artery homograft on (b)(6)1995. The right ventricle-to-pulmonary artery homograft was replaced on (b)(6) 2013. The patient was (b)(6) at the time of her cryovalve implant on (b)(6)2013. The patient pre-operative diagnosis consisted of: severe insufficiency of the right ventricle to pulmonary artery conduit statue post repair of tof, moderate stenosis of the right ventricle to pulmonary artery conduit, anomalous left anterior descending coronary artery arising from the right coronary artery. On (b)(6) 2013 the patient had a revision of the right ventricle to pulmonary artery conduit using a 24mm pulmonary homograft (sgpv00 serial identification number (b)(4). The patient presented with a pre-operative diagnosis on (b)(6) 2014 of severe pulmonary homograft stenosis. The operative procedure performed on (b)(6) 2014 included multiple redo median sternotomy, right ventricle to pulmonary artery conduit replacement using a 20-mm contegra pulmonary bovine valved conduit, and excision of keloid scar. This allograft was not returned to cryolife so no direct observations can be made. The certificate of assurance for (b)(4) was reviewed and no rejectable attributes as defined in (b)(4), cardiac allograft attributes, were documented. There are no human tissue returns associated with these allografts and no allograft-specific non-conformance reports (ncr). According to the report, a patient with multiple pulmonary valve implants for tetralogy of fallot required replacement of an sg pulmonary valve 20 months after implant for stenosis. The complainant stated that the graft failed sooner than expected although did not offer any insight as to their pre-operative expectation. Conduit stenosis is a known failure mode for allograft pulmonary valves. Stenosis is typically caused by intimal hyperplasia, a thickening of the inner layer of the conduit. The history provided indicates that the patient had a keloid scar which suggests that the patient may have a genetic pre- disposition to forming hypertrophic scars. This condition could increase the risk for intimal hyperplasia. Multiple previous surgeries may have also been a contributing factor. The root cause remains unknown; however a possible genetic pre-disposition to hypertrophic scar formation and multiple previous surgeries may have been contributing factors. The ifu lists stenosis as adverse events reported with the use of cardiac allografts. There is no indication that errors or deficiencies occurred at cryolife and the ifu communicates precautions and warnings appropriately.
Patient Sequence No: 1, Text Type: N, H10
[37763304]
Complainant offered feedback that they have identified an instance in which cryolife sg pulmonary valves became stenotic quicker than they would have expected or have seen in their past experience.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2014-00050 |
| MDR Report Key | 4262862 |
| Report Source | 04,07 |
| Date Received | 2014-11-19 |
| Date of Report | 2014-11-05 |
| Date of Event | 2014-10-23 |
| Date Mfgr Received | 2014-11-05 |
| Date Added to Maude | 2014-11-20 |
| 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 | 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 | 2014-11-19 |
| Model Number | SGPV00 |
| ID Number | 120170 (DONOR NUMBER) |
| Operator | PHYSICIAN |
| 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 | 2014-11-19 |