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.
[188403018]
Dates of event and implant: estimated dates. The udi is unknown because the part and lot numbers were not provided as this information was obtained from a literature article. There was no reported device malfunction and the product was not returned. A review of the lot history record for the reported lot could not be conducted because the part and lot numbers were not provided. The reported patient effect of thrombosis as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use (ifu) is a known adverse event associated with the use of a coronary scaffold in native coronary arteries. A conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device. The absorb device is currently not commercially available in the u. S; however, it is similar to a device sold in the us.
Patient Sequence No: 1, Text Type: N, H10
[188403019]
It was reported through a research article identifying the absorb bioresorbable vascular scaffold that may be related to serious injury. Specific patient information is documented as unknown. Details are listed in the attached article, titled, clinical, angiographic, and procedural correlates of very late absorb scaffold thrombosis multistudy registry results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02966 |
| MDR Report Key | 9884793 |
| Report Source | LITERATURE |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2016-06-01 |
| Date Mfgr Received | 2020-03-09 |
| 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. Other | 2020-03-26 |