N
Patient 1
THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.
MAUDE MDR 6364898
- MDR report key
- 6364898
- Report number
- 1063481-2017-00007
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-02-01
- Date received
- 2017-02-28
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- ROCHELLE MANEY
- Address
- 1655 ROBERTS BLVD. NW KENNESAW GA 30144 US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | CRYOVALVE SG PULMONARY VALVE AND CONDUIT | HEART VALVE, MORE THAN MINIMALLY MANIPULATED ALLOGRAFT | CRYOLIFE, INC. | OHA | SGPV00 | 134231 | R | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-02-28 | 0 | 1. H |
Event Narratives#
D
Patient 1
"PULMONARY VALVE WITH CONDUIT (SGPV00 ) ? 27 MM X 3.5 CM - SERIAL ID (B)(4), EXP. DATE: JULY 9,2020, SIZED AND MEASURED @ 22 MM ? (USING A HEGAR DILATOR ) AND SIZED / MEASURED @ 22 MM / TIGHT 23 MM (USING AN SJM VALVE SIZER) INSTEAD OF THE STATED SIZE 27 MM" PULMONARY VALVE WAS SAVED AND WILL BE RETURNED. SURGERY WAS PROLONGED AS A SYNTHETIC GRAFT WAS USED INSTEAD. THE RETURNED SPECIMEN WAS EVALUATED. TISSUE SIZE WAS TESTED WITH A SIZE 28 MM DILATOR AND WAS DETERMINED TO BE A GOOD FIT FOR THE VALVE. NEXT SIZE TEST WAS PERFORMED WITH A SIZE 22 MM DILATOR THAT PROVIDED A CLEAR VIEW INTO THE CONDUIT AND WAS DETERMINED TO BE TOO SMALL FOR THE VALVE. THE FOLLOWING SIZE TEST WAS PERFORMED WITH A SIZE 26 MM DILATOR, PROVIDING A VIEW INTO THE CONDUIT AND DETERMINED TO BE TOO SMALL FOR THE VALVE. A 27 MM DILATOR WAS USED ON THE FINAL SIZE TEST AND WAS DETERMINED TO BE AN APPROPRIATE SIZE FOR THE VALVE. UPON FURTHER EXAMINATION, THE 22 MM DILATOR WAS USED INSPECT THE SIZE OF TISSUE CONDUIT AND PROVIDED AN ACCURATE MEASURE. NO DAMAGE WAS NOTED AND TISSUE TEXTURE WAS SMOOTH.
N
Patient 1
DATA IN IS THIS A SINGLE USE DEVICE THAT WAS REPROCESSED AND REUSED ON A PATIENT? HAS BEEN CORRECTED TO "NO" THIS IS NOT A SINGLE-USE DEVICE THAT WAS REPROCESSED AND REUSED ON A PATIENT. THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.
D
Patient 1
"PULMONARY VALVE WITH CONDUIT (SGPV00 ) ? 27 MM X 3.5 CM - SERIAL ID #10701257 EXP. DATE: JULY 9,2020 SIZED AND MEASURED @ 22 MM ? (USING A HEGAR DILATOR ) AND SIZED / MEASURED @ 22 MM / TIGHT 23 MM (USING AN SJM VALVE SIZER) INSTEAD OF THE STATED SIZE 27 MM" PULMONARY VALVE WAS SAVED AND WILL BE RETURNED. SURGERY WAS PROLONGED AS A SYNTHETIC GRAFT WAS USED INSTEAD. THE RETURNED SPECIMEN WAS EVALUATED. TISSUE SIZE WAS TESTED WITH A SIZE 28 MM DILATOR AND WAS DETERMINED TO BE A GOOD FIT FOR THE VALVE. NEXT SIZE TEST WAS PERFORMED WITH A SIZE 22 MM DILATOR THAT PROVIDED A CLEAR VIEW INTO THE CONDUIT AND WAS DETERMINED TO BE TOO SMALL FOR THE VALVE. THE FOLLOWING SIZE TEST WAS PERFORMED WITH A SIZE 26 MM DILATOR, PROVIDING A VIEW INTO THE CONDUIT AND DETERMINED TO BE TOO SMALL FOR THE VALVE. A 27 MM DILATOR WAS USED ON THE FINAL SIZE TEST AND WAS DETERMINED TO BE AN APPROPRIATE SIZE FOR THE VALVE. UPON FURTHER EXAMINATION, THE 22 MM DILATOR WAS USED INSPECT THE SIZE OF TISSUE CONDUIT AND PROVIDED AN ACCURATE MEASURE. NO DAMAGE WAS NOTED AND TISSUE TEXTURE WAS SMOOTH.
N
Patient 1
THE SAMPLE WAS EVALUATED ON 02/10/2017. TISSUE SIZE TESTED WITH A SIZE 28 MM DILATOR AND WAS DETERMINED TO BE A GOOD FIT FOR THE BASAL RING. NEXT SIZE TEST WAS PERFORMED WITH A SIZE 22 MM DILATOR THAT PROVIDED A CLEAR VIEW PAST THE BASAL RING INTO THE CONDUIT AND WAS DETERMINED TO BE TOO SMALL. THE NEXT SIZE TEST WAS PERFORMED WITH A SIZE 26 MM DILATOR, PROVIDING A VIEW PAST THE BASAL RING INTO THE CONDUIT AND DETERMINED TO BE TOO SMALL AS WELL. A 27 MM DILATOR WAS USED ON THE FINAL SIZE TEST AND WAS DETERMINED TO BE AN APPROPRIATE SIZE FOR THE BASAL RING AS WELL. UPON FURTHER EXAMINATION, THE 22 MM DILATOR WAS USED INSPECT THE SIZE OF TISSUE CONDUIT AND PROVIDED AN ACCURATE MEASURE OF THE CONDUIT AND NOT OF THE BASAL RING. NO DAMAGE WAS NOTED AND TISSUE TEXTURE WAS SMOOTH. THE INSPECTOR'S TRAINING RECORDS AND SIZING CERTIFICATIONS WERE REVIEWED. THE INSPECTOR WAS CERTIFIED TO SIZE CARDIAC TISSUES PRIOR TO PERFORMING INSPECTION ON 06/15/2015 AND FOLLOWING INSPECTION ON 08/07/2015. ?THE CERTIFICATE OF ASSURANCE WAS REVIEWED. ALL ATTRIBUTES IDENTIFIED? WERE DOCUMENTED APPROPRIATELY, INCLUDING THE GRAFT SIZE. IT WAS CONFIRMED THAT THE DILATORS DOCUMENTED AT INSPECTION CORRELATE TO THE GRAFT SIZE AND ALL WERE WITHIN CALIBRATION AT THE TIME OF INSPECTION. WHILE A DEFINITIVE ROOT CAUSE IS UNKNOWN, THE SIZE DISCREPANCY NOTED BY THE COMPLAINANT MAY BE DUE TO THE DIFFERENCE IN SIZING TECHNIQUE. INFORMATION REGARDING THE SURGEON?S METHOD IS UNKNOWN. NO FURTHER ACTION NECESSARY. THIS EVENT DOES NOT IDENTIFY ADDITIONAL HAZARDS OR MODIFY THE PROBABILITY AND SEVERITY OF EXISTING HAZARDS.
D
Patient 1
"PULMONARY VALVE WITH CONDUIT (SGPV00 ) ? 27 MM X 3.5 CM - SERIAL ID (B)(4) EXP. DATE: JULY 9,2020 SIZED AND MEASURED @ 22 MM ? (USING A HEGAR DILATOR ) AND SIZED / MEASURED @ 22 MM / TIGHT 23 MM (USING AN SJM VALVE SIZER) INSTEAD OF THE STATED SIZE 27 MM" PULMONARY VALVE WAS SAVED AND WILL BE RETURNED. SURGERY WAS PROLONGED AS A SYNTHETIC GRAFT WAS USED INSTEAD.