MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 1997-08-21 for PALMAZ-SCHATZ BALLOON-EXPANDABLE STENT WITH DELIVERY SYSTEM PS1535 manufactured by New Jersey Plant.
[70341]
A coronary stent with delivery sys was successfully advanced to the target lesion site in the pt's left anterior descending artery. Upon an attempt to inflate the balloon catheter, the balloon ruptured at 8 to 9 atmospheres of pressure; however, the stent was successfully deployed. Subsequently, a dissection was reported to be observed. In response, an attempt to place another stent distal to the first stent was made. This attempt was unsuccessful due to a balloon burst (see access #2247023-1997-00252). Ultimately, a third stent was utilized and successfully deployed at the area of dissection. There were no add'l complications reported relative to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247023-1997-00251 |
| MDR Report Key | 115133 |
| Report Source | 05,06,07 |
| Date Received | 1997-08-21 |
| Date of Report | 1997-08-04 |
| Date of Event | 1997-07-31 |
| Date Facility Aware | 1997-07-31 |
| Report Date | 1997-08-04 |
| Date Reported to Mfgr | 1997-08-04 |
| Date Mfgr Received | 1997-08-04 |
| Device Manufacturer Date | 1997-07-01 |
| Date Added to Maude | 1997-08-26 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PALMAZ-SCHATZ BALLOON-EXPANDABLE STENT WITH DELIVERY SYSTEM |
| Generic Name | CORONARY STENT WITH DELIVERY SYSTEM |
| Product Code | MAF |
| Date Received | 1997-08-21 |
| Returned To Mfg | 1997-08-14 |
| Model Number | NA |
| Catalog Number | PS1535 |
| Lot Number | 135325 |
| ID Number | NA |
| Device Expiration Date | 1997-08-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 21 DAY |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 113005 |
| Manufacturer | NEW JERSEY PLANT |
| Manufacturer Address | 40 TECHNOLOGY DR. WARREN NJ 07059 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-08-21 |