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 2020-03-30 for GRAFTMASTER 1012580-19 manufactured by Abbott Vascular.
[188560428]
The device was not returned for analysis. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. The reported patient effect of perforation is listed in the graftmaster rapid exchange (rx) coronary stent graft system, domestic instructions for use (ifu) as a known patient effect of coronary stenting procedures. Additionally, a review of the complaint history did not indicate a lot specific quality issue. The investigation determined the reported failure to seal appears to be related to circumstances of the procedure. A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined. There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device. The additional graftmaster device is filed under a separate medwatch report number.
Patient Sequence No: 1, Text Type: N, H10
[188560429]
It was reported that the patient presented with a free perforation with extravasation in the mid left anterior descending artery. The patients health was declining toward death prior to use of the rx graftmaster stents. A 2. 8x16mm rx graftmaster covered stent was deployed first at 12 atmospheres (atm), but the perforation was exacerbated and did not seal. Patient developed cardiac tamponade. Then another 2. 80x19mm rx graftmaster covered stent was deployed at 16 atm, but the perforation was exacerbated and did not seal. Cardiac tamponade was still present. The patient died of coronary perforation. An autopsy was not performed. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-03074 |
| MDR Report Key | 9897573 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2018-05-11 |
| Date Added to Maude | 2020-03-30 |
| 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 | 2020-03-30 |
| Model Number | 1012580-19 |
| Catalog Number | 1012580-19 |
| Lot Number | 8051141 |
| 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 | 2020-03-30 |