MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2019-05-07 for ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM manufactured by Av-temecula-ct.
[144291909]
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Date of event, implant date, therapy date: estimated dates. The scaffolds remain in the patients. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information. The absorb device is currently not commercially available in the u. S. ; however, it is similar to a device sold in the u. S. Article titled: "oct-assessment of scaffold resorption: analysis of strut intensity by a new resorption index for poly-l-lactic acid bioresorbable vascular scaffolds. "
Patient Sequence No: 1, Text Type: N, H10
[144291910]
This case was captured based on a literature review. It was reported through a research article that absorb bioresorbable vascular scaffold stents may not reabsorb as quickly as initially assumed and may be related to thrombosis, restenosis, target lesion failure [occlusion], progression of coronary artery disease, peri-strut low intensity areas and stable angina. It was also reported that additional percutaneous coronary intervention may be required to treat in-stent restenosis of these stents. Specific patient information is documented as unknown. Details are listed in the article "oct-assessment of scaffold resorption: analysis of strut intensity by a new resorption index for poly-l-lactic acid bioresorbable vascular scaffolds. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2019-03587 |
| MDR Report Key | 8586875 |
| Report Source | LITERATURE |
| Date Received | 2019-05-07 |
| Date of Report | 2019-09-17 |
| Date of Event | 2019-03-23 |
| Date Mfgr Received | 2019-09-10 |
| Date Added to Maude | 2019-05-07 |
| 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 | LINDSEY BELL |
| 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 | 2019-05-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Hospitalization; 2. Required No Informationntervention | 2019-05-07 |