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 2020-03-09 for GRAFTMASTER 1012581-16 manufactured by Abbott Vascular.
[184054958]
(b)(4). The device was not returned for evaluation as it remains in the patient. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. It should be noted that the graftmaster was used to treat a pseudoaneurysm, but the graftmaster is indicated for use in the treatment of free perforations. In this case, it is unknown if the ifu deviation directly caused or contributed to the reported event. A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined. The reported patient effect of occlusion is listed in the graftmaster rx coronary stent graft system, instructions for use, as a known patient effect that may be associated with use of a coronary stent in native coronary arteries. There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
Patient Sequence No: 1, Text Type: N, H10
[184054959]
It was reported that three graftmaster stents were implanted overlapping each other to treat a pseudoaneurysm with extravasation in the right coronary artery. After post dilatation of the last graftmaster, the 3. 5x16 mm, there was no flow. Intracoronary nitroprusside was administered and the vessel was reballooned with a non-compliant balloon. The nitroprusside resolved the no flow. The procedure was completed with timi-3 flow. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02160 |
| MDR Report Key | 9806432 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-01-13 |
| Date Mfgr Received | 2020-02-14 |
| Device Manufacturer Date | 2019-06-04 |
| Date Added to Maude | 2020-03-09 |
| 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 | 2020-03-09 |
| Model Number | 1012581-16 |
| Catalog Number | 1012581-16 |
| Lot Number | 9060441 |
| 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 | 2020-03-09 |