MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-11-24 for TVC INSIGHT CATHETER TVC-C195-22 manufactured by Infraredx Inc..
[5228654]
The case was a planned lad intervention. Physician obtained 6 fr right radial access, inserted tvc catheter and performed a pullback in the rca. He then removed catheter and guide and advanced a different guide to the ostium of the left main and wired the lad. Physician stated there was a minor blockage at the ostium of the stenting the lad. He attempted to advance the tvc to cross the lad lesion, and therefore would not be able to use tvc for the left main. At the time he asked for volcano eagle eye catheter to evaluate the lm. Imaging revealed a mildly stenosed, but heavily calcified lm lesion. Next, physician advanced a 1. 5 rotablator burr to the lad lesion, performed multiple passes with rota before trying to remove it. He noted the burr was stuck and obtained 6 fr femoral access. He advanced a second coronary guide and wire to the ostium of the lm, and used the second system to "trap" the rota burr and remove it from the lad. Next, he placed a stent in the lad lesion. Once physician was satisfied with his intervention of the lad he asked for tvc again to scan his culprit vessel. After the lad pullback was completed, physician removed the tvc catheter, and took a picture. The angio revealed a tear in the lm. He proceeded to attempt placing a short stent in the lm to cover the tear. When the stent was deployed, it came back, and further evaluation with both angio and volcano imaging revealed that the stent was fully deployed, but free floating in the aorta. Physician upsized his femoral sheath to 10 fr and used a snare to retrieve the stent from the aorta. The stent was pulled back to the femoral artery but he was not able to remove it through the sheath. He left the stent in the femoral artery while he made a second attempt at repairing the lm tear. Upon deployment of a second stent to the lm, he noticed that the stent "watermeloned" back out of the lm. Again, further evaluation with both angio and volcano imaging was used to evaluate the location of the stent. It was decided that the stent was deployed mostly in the aorta, but enough of it was in the left main to repair the tear. Cv surgery was consulted about the stent hanging in the aorta, but it was decided that since the tear was repaired, there was nothing that could be done with the stent. Returning to the stent in the femoral, vascular surgery was consulted, and came to the cath lab to see the images. At this point, it was noted that the stent was no longer in the right femoral artery. Physician and the surgeon obtained several images of the leg, looking for the stent but they could not find it. The patient was sent to ct for further imaging in an attempt to find the stent. It was later noted that the stent had migrated from the right femoral artery, to the left profunda. The stent became lodged in a small branch of the profunda. Decision made to leave stent.
Patient Sequence No: 1, Text Type: D, B5
[12584162]
Staff at hospital reported that the left main dissection was successfully stented several days after the index catheterization on (b)(6) 2014. As noted two stents intended for the l main embolized, one to the vertebral artery and one to the leg. Neither is expected to cause harm in those locations. The patient did not experience a myocardial infarction or cardiac arrest at any time. The patient is currently doing well in a cardiac rehabilitation program that is standard for coronary patients.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004722468-2014-00002 |
| MDR Report Key | 4283604 |
| Report Source | 99 |
| Date Received | 2014-11-24 |
| Date Mfgr Received | 2014-10-23 |
| Date Added to Maude | 2014-12-02 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | STEVEN CHARTIER |
| Manufacturer Street | 34 THIRD AVENUE |
| Manufacturer City | BURLINGTON MA 018030000 |
| Manufacturer Country | US |
| Manufacturer Postal | 018030000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TVC INSIGHT CATHETER |
| Generic Name | NIRS IVUS CORONARY IMAGING CATHETER |
| Product Code | OGZ |
| Date Received | 2014-11-24 |
| Model Number | TVC-C195-22 |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INFRAREDX INC. |
| Manufacturer Address | 34 THIRD AVENUE BURLINGTON MA 01803000 US 01803 0000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-24 |