MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-04 for GRAFTMASTER 1012818-16 manufactured by Abbott Vascular.
[182138405]
The other additional graftmaster referenced is being filed under a separate medwatch report number. The device is not returning for evaluation. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
Patient Sequence No: 1, Text Type: N, H10
[182138406]
It was reported that the procedure was performed to treat a heavily calcified, moderately tortuous proximal to mid left anterior descending de novo artery that was 90% stenosed. Through radial access, pre-dilatation was done with several non-abbott nc balloons. Two non-abbott stents were implanted (a 3. 0x15mm distally and a 3. 5x30mm proximally). Post stent deployment, a perforation was noted at the overlap of the two stents. An unspecified balloon was placed to seal the perforation and a pericardium drain was placed. An attempt was made to advance a 3. 5x16mm graftmaster stent delivery system (sds) but failed to cross due to the anatomy. The graftmaster was removed and a balloon was placed to seal the perforation in the meanwhile. The graftmaster was then noted to be damaged (the type of damage was not specified). Through femoral access, a second guiding catheter was used to deploy a new 3. 5x16mm graftmaster stent at the perforation. The perforation did not seal in the middle of the stent. A balloon was placed to seal the perforation again. Then a 4. 8x19mm graftmaster stent was deployed inside of the first graftmaster stent to successfully seal the perforation. There was no adverse patient sequela reported. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-01992 |
| MDR Report Key | 9787026 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-02-06 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2019-03-26 |
| Date Added to Maude | 2020-03-04 |
| 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 | 2020-03-04 |
| Catalog Number | 1012818-16 |
| Lot Number | 9032641 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-03-04 |