MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-03 for GRAFTMASTER 1012817-19 manufactured by Abbott Vascular.
[183884365]
The device was not returned for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history did not indicate a lot specific quality issue. The investigation determined the reported failure to advance and subsequent treatment appear to be related to circumstances of the procedure. In this case, it is likely the device interacted with the heavily tortuous, heavily calcified lesion during advancement resulting in the reported failure to advance. There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
Patient Sequence No: 1, Text Type: N, H10
[183884366]
It was reported that the patient presented with a non-st-elevated myocardial infarction. The heavily tortuous and heavily calcified left anterior descending artery was being treated; however, the vessel ruptured during dilatation with an unspecified balloon catheter. An attempt to use a 2. 8x19mm rx graftmaster covered stent was made, but it failed to cross due to the anatomy. The procedure was successfully completed with balloon angioplasty. There were no reported adverse patient sequelae and no clinically significant delay in the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-01960 |
| MDR Report Key | 9781319 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-01-31 |
| Date Mfgr Received | 2020-02-13 |
| Device Manufacturer Date | 2019-01-30 |
| Date Added to Maude | 2020-03-03 |
| 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 | MS. LINDSEY BELL |
| Manufacturer Street | 26531 YNEZ RD. |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal | 925914628 |
| Manufacturer Phone | 9519143996 |
| Manufacturer G1 | ABBOTT VASCULAR, REG # 3005718570 (P099) |
| Manufacturer Street | CASHEL ROAD |
| Manufacturer City | CLONMEL TIPPERARY |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GRAFTMASTER |
| Generic Name | CORONARY STENT DELIVERY SYSTEM |
| Product Code | MAF |
| Date Received | 2020-03-03 |
| Catalog Number | 1012817-19 |
| Lot Number | 9013041 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT VASCULAR |
| Manufacturer Address | 26531 YNEZ RD. TEMECULA CA 925914628 US 925914628 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-03 |