MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2020-03-26 for ABSORB UNK ABSORB manufactured by Abbott Vascular.
[185183456]
The unique device identifier (udi) is unknown because the part and lot numbers were not provided. The devices remain in the patients. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The thrombus, myocardial infarction, angina, dyspnea, and occlusion, requiring medication, revascularization and re-hospitalization, and the device malfunction of wall apposition mentioned are filed under separate mfr numbers. Literature: bioresorbable coronary scaffold thrombosis multicenter comprehensive analysis of clinical presentation mechanisms and predictors. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185183457]
This is filed to report the deaths. It was reported through a research article identifying the absorb bioresorbable vascular scaffold (bvs) that may be related to the following: death, thrombus, myocardial infarction, angina, dyspnea, and occlusion, requiring medication, revascularization and re-hospitalization, and the device malfunction of wall apposition. Details are listed in the attached article, titled bioresorbable coronary scaffold thrombosis multicenter comprehensive analysis of clinical presentation mechanisms and predictors. Please see article for additional information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-03008 |
| MDR Report Key | 9887129 |
| Report Source | LITERATURE |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2012-05-01 |
| Date Mfgr Received | 2020-03-05 |
| Date Added to Maude | 2020-03-26 |
| 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 | 2020-03-26 |
| 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. Death | 2020-03-26 |