MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2019-03-01 for ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM manufactured by Av-temecula-ct.
[137588924]
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Date of event, implant date: estimated dates. The absorb device is currently not commercially available in the u. S; however, it is similar to a device sold in the u. S. Product performance engineering reviewed the incident information; however, there was no reported device malfunction and the product was not returned. A review of the lot history record and complaint history could not be conducted because the part and lot number were not provided. The reported patient effects of occlusion and thrombosis, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use are known adverse events associated with the use of a coronary scaffold in native coronary arteries. A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined. There is no indication of a product quality issue with respect to design, manufacture or labeling of the device. The unk xience device referenced is being filed under a separate medwatch report. Literature: "clinical outcomes at 2 years of the absorb bioresorbable vascular scaffold versus the xience drug-eluting metallic stent in patients presenting with acute coronary syndrome versus stable coronary disease - aida trial sub-study. "
Patient Sequence No: 1, Text Type: N, H10
[137588926]
It was reported through a research article that absorb bioresorbable vascular scaffold stents and xience drug-eluting stents may be related to thrombosis and target vessel failure [occlusion]. Specific patient information is documented as unknown. Details are listed in the article, title: "clinical outcomes at 2 years of the absorb bioresorbable vascular scaffold versus the xience drug-eluting metallic stent in patients presenting with acute coronary syndrome versus stable coronary disease - aida trial sub-study. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2019-01600 |
| MDR Report Key | 8383275 |
| Report Source | LITERATURE |
| Date Received | 2019-03-01 |
| Date of Report | 2019-06-19 |
| Date of Event | 2019-02-01 |
| Date Mfgr Received | 2019-06-10 |
| Date Added to Maude | 2019-03-01 |
| 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 | CONNIE SPECK |
| Manufacturer Street | ABBOTT VASCULAR 26531 YNEZ ROAD |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal | 925914628 |
| Manufacturer Phone | 9519143996 |
| Manufacturer G1 | ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168 |
| Manufacturer Street | ABBOTT VASCULAR 26531 YNEZ ROAD |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 925914628 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM |
| Generic Name | BIORESORBABLE DRUG ELUTING SCAFFOLD |
| Product Code | PNY |
| Date Received | 2019-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AV-TEMECULA-CT |
| Manufacturer Address | ABBOTT VASCULAR 26531 YNEZ ROAD TEMECULA CA 925914628 US 925914628 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2019-03-01 |