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 2019-03-16 for GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM 1012582-16 manufactured by Av-temecula-ct.
[139035670]
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. (b)(4). The device was not returned for evaluation. The reported patient effect of occlusion as listed in the graftmaster rx coronary stent graft system, instructions for use (ifu), is a known patient effect that may be associated with use of a coronary stent in native coronary arteries. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Based on the information reviewed, there is no indication of a product quality issue. It should be noted that the graftmaster rapid exchange (rx), coronary stent graft system, domestic instructions for use, (ifu) states: the graftmaster rx is indicated for use in the treatment of free perforations, defined as free contrast extravasation into the pericardium, in native coronary vessels or saphenous vein bypass grafts. It is unknown if the ifu deviation contributed to the reported event. A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined. There is no indication of a product quality issue with respect to manufacture, design or labeling of the device. The other graftmaster devices referenced are being filed under separate medwatch report numbers.
Patient Sequence No: 1, Text Type: N, H10
[139035671]
It was reported that during a procedure, following rotational atherectomy, the patient presented with a free perforation with extravasation in the mid left anterior tibial artery. Anticoagulation was reversed and angioplasty with an unspecified 2. 0 mm balloon dilatation catheter was performed for a total time of 15 to 20 minutes; however, the perforation failed to seal. In order to prevent compartment syndrome, three graftmaster covered stents (2. 80x16, 3. 50x16 and 4. 00x16 mm) were deployed to treat the perforation. Three covered stents were used to treat the perforation due to the size of the lesion and the stent sizes in stock and available. Each stent sealed the perforation in the area they were deployed and there were no reported issues with stent deployment. Angiography performed post stent placement demonstrated no evidence of perforation [no further extravasation] and no evidence of compartment syndrome; however, the initial improvement in flow achieved in the left anterior tibial artery was lost. The reversal of the anticoagulation, prolonged balloon inflation and the placement of the graftmaster covered stents resulted in re-occlusion of the mid left anterior tibial artery. It could not be confirmed how many of the stents were re-occluded post procedure. Routine post procedure care was performed and further revascularization of the left anterior tibial artery through the covered stents may be performed at a later date. There has been no further additional intervention performed at this time and the patient was reported to be doing well. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2019-02065 |
| MDR Report Key | 8426752 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-16 |
| Date of Report | 2019-03-15 |
| Date of Event | 2019-03-01 |
| Date Mfgr Received | 2019-03-06 |
| Device Manufacturer Date | 2018-06-01 |
| Date Added to Maude | 2019-03-16 |
| 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 | CONNIE SPECK |
| Manufacturer Street | ABBOTT VASCULAR 26531 YNEZ ROAD |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal | 925914628 |
| Manufacturer Phone | 9519143996 |
| Manufacturer G1 | CLONMEL, IRELAND REG# 9616693 |
| Manufacturer Street | ABBOTT VASCULAR 26531 YNEZ ROAD |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 925914628 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM |
| Generic Name | CORONARY STENT GRAFT |
| Product Code | MAF |
| Date Received | 2019-03-16 |
| Catalog Number | 1012582-16 |
| Lot Number | 8062241 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AV-TEMECULA-CT |
| Manufacturer Address | ABBOTT VASCULAR 26531 YNEZ ROAD TEMECULA CA 925914628 US 925914628 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-16 |