MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-08-02 for ACIST NAVVUS 014667 manufactured by Acist Medical Systems, Inc..
[115887435]
The navvus catheter was discarded by the user facility and the lot number was not provided; therefore, acist is unable to evaluate the catheter. On (b)(6) 2018, the user facility provided a copy of the cine-angiogram of the event to acist. Upon completion of the review of the cine-angiogram by acist's medical advisory board members, a follow-up report will be submitted to fda.
Patient Sequence No: 1, Text Type: N, H10
[115887436]
User facility reported, during a percutaneous coronary intervention (pci) of the left coronary (lc), upon insertion of the acist navvus catheter into the lc to obtain the fractional flow reserve (ffr) reading, the patient went into ventricular fibrillation. A dissection of the left main artery was seen on fluoroscopy. The physician was unable to regain access of the left main artery. Patient death occurred.
Patient Sequence No: 1, Text Type: D, B5
[118786346]
Acist's medical advisory board reviewed a copy of the cine-angiogram and information received from the user facility from the event: the user facility reported that the left main (lm) coronary was dissected during a fractional flow reserve (ffr) measurement with a navvus catheter. Despite resuscitative measures, including an impella pump, the patient died. A review of the angiogram showed an initial diagnostic study in which there was moderate diffuse coronary narrowing. The mid left anterior descending (lad) artery and circumflex artery had intermediate lesions. The right coronary artery (rca) may have been occluded distally and had collateral flow from the left coronary. An lv angiogram, with an end-hole catheter, showed normal systolic function. The next angiogram showed a guidewire in the distal lad, an inflated balloon in the left main proximal lad, cpr, and an impella pump. A guide wire was then passed distally down the lad. A balloon is shown inflated in the mid lad. The guidewire later was removed and repassed. An angiogram near the end showed a large dissection in the mid lad with contrast hang-up. The lm and very proximal lad were clear. From the data presented, there was a dissection somewhere in the left coronary. Angiographically it appeared to be only in the lad; there were no fluoro images provided by the user facility that may have shown lm involvement and no images that show whether the dissection was due to the guidewire or navvus catheter. The cause of this event is inconclusive.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134243-2018-00017 |
| MDR Report Key | 7744990 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-08-02 |
| Date of Report | 2018-08-28 |
| Date of Event | 2018-06-28 |
| Date Mfgr Received | 2018-08-03 |
| Date Added to Maude | 2018-08-02 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | JEFF AUDRITSH |
| Manufacturer Street | 7905 FULLER ROAD |
| Manufacturer City | EDEN PRAIRIE MN 55344 |
| Manufacturer Country | US |
| Manufacturer Postal | 55344 |
| Manufacturer Phone | 9529959347 |
| Manufacturer G1 | ACIST MEDICAL SYSTEMS, INC. |
| Manufacturer Street | 7905 FULLER ROAD |
| Manufacturer City | EDEN PRAIRIE MN 55344 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55344 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACIST |
| Generic Name | CATHETER, PRESSURE MONITORING, CARDIAC |
| Product Code | OBI |
| Date Received | 2018-08-02 |
| Model Number | NAVVUS |
| Catalog Number | 014667 |
| Lot Number | NOT PROVIDED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACIST MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 7905 FULLER ROAD EDEN PRAIRIE MN 55344 US 55344 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-08-02 |