MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for ABSOLUTE PRO BILIARY 1011915-080 manufactured by Abbott Vascular.
[185725748]
The device was received. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information.
Patient Sequence No: 1, Text Type: N, H10
[185725749]
It was reported that the procedure was to treat a distal superficial femoral artery. A 6. 0x80mm absolute pro stent was advanced to the lesion and deployed without issue. However, it was noted that there was resistance with the anatomy when advancing. When the absolute pro delivery system was being retrieved, resistance was met with the 6fr sheath and the outer sheath of the absolute pro tore off (remaining within the sheath). The absolute pro and introducer sheath were then removed all together. There were no adverse patient effects and no clinically significant delay in the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-03134 |
| MDR Report Key | 9903652 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2019-06-05 |
| Date Added to Maude | 2020-03-31 |
| 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 | MS. LINDSEY BELL |
| Manufacturer Street | 26531 YNEZ RD. |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal | 925914628 |
| Manufacturer Phone | 9519143996 |
| Manufacturer G1 | ABBOTT VASCULAR, REG # 2024168 |
| Manufacturer Street | 26531 YNEZ ROAD |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 925914628 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABSOLUTE PRO BILIARY |
| Generic Name | SELF EXPANDING PERIPHERAL STENT SYSTEM |
| Product Code | FGE |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-31 |
| Catalog Number | 1011915-080 |
| Lot Number | 9060561 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT VASCULAR |
| Manufacturer Address | 26531 YNEZ RD. TEMECULA CA 925914628 US 925914628 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |