ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-07-02 for ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM manufactured by Av-temecula-ct.

MAUDE Entry Details

• Report Number: 2024168-2019-05313
• MDR Report Key: 8755070
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2019-07-02
• Date of Report: 2019-07-23
• Date of Event: 2019-06-10
• Date Mfgr Received: 2019-07-16
• Date Added to Maude: 2019-07-02
• 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

Device Details

• Brand Name: ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Generic Name: BIORESORBABLE DRUG ELUTING SCAFFOLD
• Product Code: PNY
• Date Received: 2019-07-02
• 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

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2019-07-02