MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2005-03-10 for TFE COATED LUNDERQUIST EXTRA STIFF WIRE GUIDE TSMG-35-260-3-LES2 manufactured by Cook, Incorporation.
[345156]
Main body graft was advanced via a left femoral apprach into the aorta. Angulation of the aorta infrarenally was in excess of sixty degrees and complicated device delivery. The tortuous anatomy in the iliac arteries resulted in difficulty advancing the wire and delivery sheaths through the vessels. As a result of the present totruosity, the physician had difficulty docking the top cap with the grey positioner. Utilizing a balloon catheter, the top cap was successfully pulled downward upon the grey positioner. Prevalent tortuosity in the aorta and iliac arteries, resulted in the placement of additional stents. Two stents were required in the main body at the proximal portion of the graft, and one each in the contralateral and ipsilateralleg grafts. An improved flow through the graft and a decrease in the angle was observed after placement. During mid-procedure a noted profusion of blood was observed, in conjuction with a drop in the patient's blood pressure, bp was maintained and a transesophageal examination (tee) was preformed noting a ventricular perforation. The lunderquist wire had been passed beyond the aortic arch through the aortic valve and into the left ventricle causing the ventricular perforation. Patient had then developed a cardiac tamponade which was initially treated with catheter aspiration, but ultimately required a median sternotomy and several sutures to repairs the hole. Zenith implant procedures was succcessfully completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2005-00088 |
| MDR Report Key | 580581 |
| Report Source | 05,07 |
| Date Received | 2005-03-10 |
| Date of Report | 2005-02-09 |
| Date of Event | 2005-02-08 |
| Date Facility Aware | 2005-02-08 |
| Report Date | 2005-02-09 |
| Date Mfgr Received | 2005-02-09 |
| Date Added to Maude | 2005-03-14 |
| 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 | RITA HARDEN |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TFE COATED LUNDERQUIST EXTRA STIFF WIRE GUIDE |
| Generic Name | WIRE GUIDE |
| Product Code | DOX |
| Date Received | 2005-03-10 |
| Model Number | NA |
| Catalog Number | TSMG-35-260-3-LES2 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 570428 |
| Manufacturer | COOK, INCORPORATION |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US |
| Baseline Brand Name | TFE COATED LUNDERQUIST: EXTRA STIFF WIRE GUIDE |
| Baseline Generic Name | NA |
| Baseline Model No | NA |
| Baseline Catalog No | TSMG-35-260-7-LES2 |
| Baseline ID | NA |
| Baseline Device Family | WIRE GUIDE |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-03-10 |