MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2020-03-19 for ABSORB UNK ABSORB manufactured by Abbott Vascular.
[187030344]
Date of event and implant: estimated date. The scaffold remains in the patient. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information. The xience referenced is being filed under a separate medwatch report number.
Patient Sequence No: 1, Text Type: N, H10
[187030345]
It was reported through a research article identifying absorb and xience that may be related to the following; myocardial infarction, device thrombosis, re-hospitalization and final minimal lumen diameter of the scaffold and stent. Additionally, a general statement was made regarding dissatisfaction with absorb. Specific patient information is documented as unknown. Details are listed in the attached article, titled "outcomes of optimised implantation technique with bioresorbable scaffolds: a pooled analysis of absorb-iv and compare-absorb trials".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02639 |
| MDR Report Key | 9855709 |
| Report Source | LITERATURE |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2019-07-18 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2020-03-19 |
| 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 | 2020-03-19 |
| 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. Deathisabilit | 2020-03-19 |