MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2019-02-21 for ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM manufactured by Av-temecula-ct.
[136753421]
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Date of event has been estimated based on date of article publication. Date of implant has been estimated based on date of first patient enrollment. Alert date has been estimated based on date the article was read. The scafold remains in the patient. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. Literature attachment: angiographic and midterm outcomes of bioresorbable vascular scaffold for coronary bifurcation lesions. Author- pieter smits, american journal of cardiology 122. 12: 2035-2042. Elsevier inc. (dec 15, 2018). The additional patient deaths and malapposed scaffold struts referenced in the article are being filed under separate medwatch report #s.
Patient Sequence No: 1, Text Type: N, H10
[136753422]
It was reported through a data review of 107 patients between july 2009 and december 2015 identifying absorb bioresorbable vascular scaffolds (bvs) that may be related to major adverse cardiac events of myocardial infarction (mi), target lesion revascularization (tlr), target vessel revascularization (tvr), target lesion failure (stenosis), dissection, thrombosis and hospitalization. Specific patient information is documented as unknown. Details are listed in the attached article, titled "angiographic and midterm outcomes of bioresorbable vascular scaffold for coronary bifurcation lesions".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2019-01274 |
| MDR Report Key | 8358058 |
| Report Source | LITERATURE |
| Date Received | 2019-02-21 |
| Date of Report | 2019-03-25 |
| Date of Event | 2018-06-13 |
| Date Mfgr Received | 2019-03-05 |
| Date Added to Maude | 2019-02-21 |
| 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 | 2019-02-21 |
| 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. Required No Informationntervention | 2019-02-21 |