MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-25 for STENTS ADVANTA V12 85343 - ADVANTA V12 COVERED STENT 6MMX22MMX80CM 85343 manufactured by Atrium Medical Corporation.
[153221835]
On completion of the investigation a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[153221836]
The 6 x 22 x 80 was used in the left renal for a fenestrated evar case with a 6fr anl cook sheath. The balloon was inflated with 1/3, 2/3 contrast and saline. Once the balloon was deflated the clinician struggled to get the balloon back in to the sheath. The stent was deployed successfully and there was no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011175548-2019-00806 |
| MDR Report Key | 8828327 |
| Date Received | 2019-07-25 |
| Date of Report | 2019-07-25 |
| Date of Event | 2019-07-15 |
| Date Mfgr Received | 2019-08-16 |
| Device Manufacturer Date | 2019-04-30 |
| Date Added to Maude | 2019-07-25 |
| 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 Street | 40 CONTINENTAL BLVD |
| Manufacturer City | MERRIMACK NH 03054 |
| Manufacturer Country | US |
| Manufacturer Postal | 03054 |
| Manufacturer G1 | ATRIUM MEDICAL CORPORATION |
| Manufacturer Street | 40 CONTINENTAL BLVD |
| Manufacturer City | MERRIMACK NH 03054 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 03054 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STENTS ADVANTA V12 |
| Generic Name | STENT, RENAL |
| Product Code | NIN |
| Date Received | 2019-07-25 |
| Returned To Mfg | 2019-08-05 |
| Model Number | 85343 - ADVANTA V12 COVERED STENT 6MMX22MMX80CM |
| Catalog Number | 85343 |
| Lot Number | 446054 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATRIUM MEDICAL CORPORATION |
| Manufacturer Address | 40 CONTINENTAL BLVD MERRIMACK NH 03054 US 03054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-07-25 |