MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2019-11-26 for ABSORB UNK ABSORB manufactured by Abbott Vascular.
[168058736]
Udi # - in the absence of reported part number, udi could not be provided. Exemption number (b)(4). There was no reported device malfunction and the product was not returned as the scaffold remains in the anatomy. A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot number were not provided. Based on the case information a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined. The reported patient effect of dissection, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use is a known adverse event associated with the use of a coronary scaffold in native coronary arteries. There is no indication of a product quality issue with respect to design, manufacture or labeling of the device. Attached, article title: "acute angiographic and intermediate-term clinical results of patients with non-left main coronary bifurcation lesions treated with bvs by jailed semi-inflated balloon technique and provisional side-branch stenting strategy. " 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
[168058737]
It was reported through a research article that the abbott bioresorbable vascular scaffold may be related to some dissections that occurred during the coronary procedure. Details are listed in the attached article, titled acute angiographic and intermediate-term clinical results of patients with non-left main coronary bifurcation lesions treated with bvs by jailed semi-inflated balloon technique and provisional side-branch stenting strategy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2019-13926 |
| MDR Report Key | 9377412 |
| Report Source | LITERATURE |
| Date Received | 2019-11-26 |
| Date of Report | 2019-11-26 |
| Date of Event | 2017-12-01 |
| Date Mfgr Received | 2019-11-05 |
| Date Added to Maude | 2019-11-26 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2019-11-26 |
| 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 | 2019-11-26 |