MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2019-02-01 for ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM manufactured by Av-temecula-ct.
[134860869]
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Literature attachment: the demise of the absorb bvs: lessons learned from the discontinuation of a disappearing stent. Date of event has been estimated. Date of implant has been estimated. The scaffold remains in the patient. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information. The additional adverse patient effects referenced in the article are being filed under a separate medwatch report #.
Patient Sequence No: 1, Text Type: N, H10
[134860870]
It was identified through review of the article that the absorb bioresorbable vascular scaffold (bvs) may be related to under-expansion and mal-apposition of the scaffold. It is unknown what intervention was performed, if any. Details are listed in the article, titled, "the demise of the absorb bvs: lessons learned from the discontinuation of a disappearing stent".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2019-00761 |
| MDR Report Key | 8297628 |
| Report Source | LITERATURE |
| Date Received | 2019-02-01 |
| Date of Report | 2019-02-15 |
| Date of Event | 2018-12-02 |
| Date Mfgr Received | 2019-02-11 |
| Date Added to Maude | 2019-02-01 |
| 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 | 2019-02-01 |
| 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 | 2019-02-01 |