MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2019-11-27 for ABSORB UNK ABSORB manufactured by Abbott Vascular.
[168457159]
Date of event, implant date: estimated dates. Exemption number (b)(4). The scaffolds remain in the patients. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information. The additional patient effect of death referenced is being filed under a separate medwatch report number. The absorb device is currently not commercially available in the u. S; however, it is similar to a device sold in the u. S.
Patient Sequence No: 1, Text Type: N, H10
[168457160]
Details are listed in the attached article, titled? Poly (l-lactic acid) bioresorbable scaffolds versus metallic drugeluting stents for the treatment of coronary artery disease: a meta-analysis of 11 randomized trials. " it was reported through a research article identifying absorb bioresorbable vascular scaffolds that may be related to the following: patients experiencing cardiovascular mortality, myocardial infarction, restenosis, target lesion failure, ischemic complications, thrombosis related to malapposed scaffolds and target lesion revascularization. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2019-13996 |
| MDR Report Key | 9387074 |
| Report Source | LITERATURE |
| Date Received | 2019-11-27 |
| Date of Report | 2019-11-27 |
| Date of Event | 2019-11-15 |
| Date Mfgr Received | 2019-11-26 |
| Date Added to Maude | 2019-11-27 |
| 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 | 2019-11-27 |
| 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 | 2019-11-27 |