MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-31 for PROCOL BIOLOGIC VASCULAR GRAFT HJL016-10-N manufactured by Lemaitre Vascular, Inc..
[125748070]
We have received the explanted graft for evaluation and we have confirmed the reported incident. About 2 cm at one end of the graft was found to have dilated to about 12 mm while the rest of the graft remained undilated. There was no valve observed inside the graft that could have otherwise impeded the flow. No major difference in thickness between this section of the graft to other section of the graft was observed. However, this section of the graft appears to have experienced some trauma to the intima of the vein. At this time, we cannot confirm if there was a thrombosis or it was a weak vessel wall that contributed to vessel aneurysm. A histology report comparing this dilated section of the graft to undilated section of the graft is currently pending. Surgeon confirmed that the graft was properly flushed with heparin. As stated in our ifu, adverse events including thrombosis/occlusion of the graft could occur with the use of this vascular access graft. Our procol clinical data had shown that the graft may require intervention prior to 6 months after implant. The results from the preclinical and clinical data provide reasonable assurance that the procol device is safe and effective for patients who already have at least one failed prosthetic access graft. There was no injury to the patient as the result of the incident. A new procol graft was implanted to replace the explanted graft.
Patient Sequence No: 1, Text Type: N, H10
[125748071]
The graft dilated at the arterial end once the blood flow was introduced into the graft after performing the arterial anastomosis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2018-00093 |
| MDR Report Key | 8025977 |
| Date Received | 2018-10-31 |
| Date of Report | 2018-10-31 |
| Date of Event | 2018-10-01 |
| Date Mfgr Received | 2018-10-01 |
| Device Manufacturer Date | 2014-02-15 |
| Date Added to Maude | 2018-10-31 |
| 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 01803 |
| Manufacturer Country | US |
| Manufacturer Postal | 01803 |
| Manufacturer Phone | 7812212266 |
| Manufacturer G1 | LEMAITRE VASCULAR |
| Manufacturer Street | 63 SECOND AVE |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01803 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PROCOL BIOLOGIC VASCULAR GRAFT |
| Generic Name | VASCULAR GRAFT |
| Product Code | LXA |
| Date Received | 2018-10-31 |
| Returned To Mfg | 2018-10-22 |
| Catalog Number | HJL016-10-N |
| Lot Number | 016-T2725-22 |
| Device Expiration Date | 2019-08-29 |
| 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 01803 US 01803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-31 |