MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2019-11-18 for ABSORB UNK ABSORB manufactured by Abbott Vascular.
[168001358]
Patient age: median age. Sex: 51. 6% male gender. Date of event, test date, implant date, therapy date: estimated date. (b)(4). The absorb device is currently not commercially available in the u. S; however, it is similar to a device sold in the us. The scaffold remains in the patient. 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
[168001359]
It was reported through a literature article that the absorb bioresorbable vascular scaffolds (bvs) may be related to target vessel revascularization, amputation and restenosis. Specific patient information is documented as unknown. Details are listed in the attached article, titled "single arm retrospective study of bioresorbable vascular scaffolds to treat patients with severe infrapopliteal arterial disease". No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2019-13709 |
| MDR Report Key | 9337403 |
| Report Source | LITERATURE |
| Date Received | 2019-11-18 |
| Date of Report | 2019-11-18 |
| Date of Event | 2019-10-05 |
| Date Mfgr Received | 2019-11-05 |
| Date Added to Maude | 2019-11-18 |
| 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 | ABSORB |
| Generic Name | BIORESORBABLE SCAFFOLD |
| Product Code | PNY |
| Date Received | 2019-11-18 |
| Catalog Number | UNK ABSORB |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit | 2019-11-18 |