MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,s report with the FDA on 2020-01-02 for ABSORB 1234300-12 manufactured by Abbott Vascular.
[176567749]
Date of event estimated. Exemption number e2019001. The device remains in 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
[176567750]
Patient id (b)(6). It was reported that the patient underwent a coronary procedure on (b)(6) 2016, with implantation of two absorb gt1 bioresorbable vascular scaffolds (bvs) in the mid to distal right coronary artery (rca). In (b)(6) 2018, the patient began to experience worsening coronary artery disease and was re-hospitalized. On (b)(6) 2019 a revascularization procedure was performed, treating the mid rca with implantation of an additional stent. The patient condition resolved on (b)(6) 2019. There was no additional information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-00094 |
| MDR Report Key | 9540363 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2020-01-02 |
| Date of Report | 2020-02-21 |
| Date of Event | 2018-07-01 |
| Date Mfgr Received | 2020-02-04 |
| Device Manufacturer Date | 2015-08-26 |
| Date Added to Maude | 2020-01-02 |
| 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 | 2020-01-02 |
| Catalog Number | 1234300-12 |
| Lot Number | 5082661 |
| Device Expiration Date | 2017-02-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-01-02 |