MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-19 for PROCOL BIOLOGIC VASCULAR GRAFT HJL016-40-N manufactured by Lemaitre Vascular, Inc..
[185004755]
We have received the explanted graft for evaluation. However, we were unable to investigate the returned graft. The graft has already decayed by the time of our device evaluation since it was returned to us without being submergerd in sterile solution. We have also received a picture of the reported defect from the surgeon. In the provided picture, we observed the proximal end of the graft had dilated twice the diameter of its distal section. The procol graft is a natural vein with competent valves. As stated in the ifu, the beveled cut end is the inflow end of the vessel. The graft should not be implanted or flushed in the opposite direction of flow as competent valves may cause excessive pressure and damage the integrity of the vessel. Our inquiry with the implanting physician revealed that he believed that he had implanted the device in the correct orientation. But the picture provided conflicted with that description. Therefore, we are not conclusive on the exact root cause of this failure. Our review of the lot history records for this lot did not find any discrepancies either in the manufacturing or packaging process that could be related to this incident. Further, we have not received any other complaints of a similar nature for devices from this lot. Hence, we consider this to be an isolated incident. Please note that each graft is pressurized between 2. 7-4. 0 psi ( 139 - 206 mmhg) during the inspection process. If pressure exceeds 4 psi, the vessel is rejected for 'overpressurized' and discarded. Under a pressurized condition, each graft is inspected by the manufacturing operators for any presence of hole, tear or swelling. An od gage is passed over the entire length of the vessel. If any section of the graft appeared to be dilated or did not pass through the gage smoothly, then that section of the graft is rejected by the technician. Each graft is again inspected by the qc technician for these attributes. Physician implanted another procol vascular graft without any issue.
Patient Sequence No: 1, Text Type: N, H10
[185004756]
Surgeon used a procol vascular bioprosthesis for creating a bridge graft for vascular access in a dialysis patient. After completion of arterial anastomosis, when surgeon removed the clamp and the graft was under arterial pressure, he observed the proximal end of the graft had dilated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2020-00021 |
| MDR Report Key | 9729589 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-01-20 |
| Date Mfgr Received | 2020-01-20 |
| Device Manufacturer Date | 2019-08-27 |
| Date Added to Maude | 2020-02-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PRAGYA THIKEY |
| Manufacturer Street | 63 SECOND AVE |
| Manufacturer City | BURLINGTON, MA |
| Manufacturer Country | US |
| Manufacturer Phone | 2212266152 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROCOL BIOLOGIC VASCULAR GRAFT |
| Generic Name | VASCULAR GRAFT, |
| Product Code | LXA |
| Date Received | 2020-02-19 |
| Returned To Mfg | 2020-01-28 |
| Model Number | HJL016-40-N |
| Catalog Number | HJL016-40-N |
| Lot Number | PVB1044 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEMAITRE VASCULAR, INC. |
| Manufacturer Address | 63 SECOND AVE BURLINGTON, MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-19 |