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 2020-03-26 for GRAFTMASTER UNK RX GRAFTMASTER manufactured by Abbott Vascular.
[188205655]
Dates of event and implant: estimated dates. Attachment literature titled: "restenosis of a polytetrafluoroethylene-covered stent visualized by coronary angioscopy and optical coherence tomography: a case report" the device will not be returned for evaluation as the stent remains in the patient. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information. The xience referenced is being filed under a separate medwatch report.
Patient Sequence No: 1, Text Type: N, H10
[188205656]
It was reported in a literature article that the 3. 5x18 mm xience alpine stent was implanted and a perforation was noted. Prolonged balloon inflation was performed, but did not achieve hemostasis. This was followed by the placement of the 3. 5x19 mm graftmaster implanted inside the xience stent; this successfully treated the perforation and stopped the bleeding. The chest pain resolved and the patient was discharged home two days post procedure. Six months later, the effort angina returned; angiogram found a focal restenosis on the distal edge of the graftmaster. Percutaneous coronary intervention was performed using optical coherence tomography (oct) and angiogram. Oct found extremely focal restenosis with homogeneous neointima. There were exposed struts in the middle and proximal segment of the graftmaster stent. There was no thrombus found. The restenosis was treated with the implantation of a 3. 0x9 mm non-abbott, biodegradable sirolimus-eluting stent. Six months later, the patient had angina again. There was stenosis in the non-abbott stent. This was treated with balloon angioplasty using a 3. 0x20 mm drug-coated balloon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02960 |
| MDR Report Key | 9884551 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2018-10-01 |
| Date Mfgr Received | 2020-03-09 |
| Date Added to Maude | 2020-03-26 |
| 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 |
| Manufacturer Street | 26531 YNEZ RD. |
| Manufacturer City | TEMECULA |
| 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 | 2020-03-26 |
| Catalog Number | UNK RX GRAFTMASTER |
| Lot Number | UNK |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-03-26 |