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 2019-08-02 for ABSORB UNK ABSORB manufactured by Abbott Vascular.
[153167782]
Date of implant, estimated. Exemption number (b)(4) permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition. There may be gaps in numbering for reports submitted during the transition period. The scaffold remains in the patient. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. Na.
Patient Sequence No: 1, Text Type: N, H10
[153167783]
It was reported that approximately 3 years post absorb bioresorbable vascular scaffold (bvs) implantation in the right coronary artery, the patient may have experienced angina. On (b)(6) 2019, optical coherence tomography (oct) was performed, and it was noted that the bvs had not yet been resorbed and restenosis was seen. Angioplasty was performed using a drug eluting balloon to treat the restenosis. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2019-10543 |
| MDR Report Key | 8857679 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-08-02 |
| Date of Report | 2019-08-02 |
| Date of Event | 2019-06-26 |
| Date Mfgr Received | 2019-07-11 |
| Date Added to Maude | 2019-08-02 |
| 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. CONNIE SPECK |
| 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 | 2019-08-02 |
| 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 | 2019-08-02 |