MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2018-01-12 for PROCOL BIOLOGIC VASCULAR GRAFT HJL016-40-N manufactured by Lemaitre Vascular, Inc..
[97274190]
We have received a piece of the explanted graft for evaluation. However, the returned section of the graft was not the section that had occlusion. The inner surface of the graft looked smooth and did not show any sign of occlusion. Doctor had also mentioned that he found a hole in the graft. Doctor thinks he might have punctured the graft while dissecting. So, he replaced that section of the graft with a different procol graft. A thrombectomy is usually performed to remove the thrombus using standard atraumatic percutaneous or surgical techniques 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 month 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. (b)(4) units from this lot has been sold. We have not received any other complaint related to this lot or any other procol lot for a similar incident. Hence, we consider this to be an isolated incident. 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
[97274191]
The procol vascular bioprosthesis graft was placed in the lower right arm for av access. After three weeks of implant, when doctor attempted to declot the graft, he found that the graft had occluded at the apex of the graft. He also found a hole in the graft. So, he sewed both ends and abandoned the graft.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2018-00001 |
| MDR Report Key | 7187515 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-01-12 |
| Date of Report | 2018-01-12 |
| Date of Event | 2017-12-15 |
| Date Mfgr Received | 2017-12-15 |
| Date Added to Maude | 2018-01-12 |
| 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 | 3 |
| Brand Name | PROCOL BIOLOGIC VASCULAR GRAFT |
| Generic Name | VASCULAR GRAFT |
| Product Code | LXA |
| Date Received | 2018-01-12 |
| Returned To Mfg | 2018-01-02 |
| Catalog Number | HJL016-40-N |
| Lot Number | 016-T2791-07 |
| Operator | PHYSICIAN |
| 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 | 2018-01-12 |