MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-10-30 for ABSORB UNK UNK ABSORB manufactured by Abbott Vascular.
[164439362]
Exemption number (b)(4). Date of event has been estimated. Date of implant has been estimated. The device will not be returned for evaluation. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. Literature: absorb bioresorbable scaffolds? Out of the woods after 3 years?
Patient Sequence No: 1, Text Type: N, H10
[164439363]
It was reported through an article titled, 'absorb bioresorbable scaffolds? Out of the woods after 3 years? ' identifying absorb bioresorbable scaffolds that may be related to major adverse cardiac events of myocardial infarction and thrombosis. Dual anti-platelet therapy was used as treatment. Specific patient information is documented as unknown. Details are listed in the attached article.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2019-13048 |
| MDR Report Key | 9257357 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-10-30 |
| Date of Report | 2019-10-30 |
| Date of Event | 2019-09-27 |
| Date Mfgr Received | 2019-10-07 |
| Date Added to Maude | 2019-10-30 |
| 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 |
| Manufacturer Street | 26531 YNEZ RD. |
| 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 | 2019-10-30 |
| Model Number | UNK |
| Catalog Number | UNK ABSORB |
| Lot Number | UNK |
| 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. Required No Informationntervention | 2019-10-30 |