MAUDE Adverse Event Report: AV-TEMECULA-CT ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE DRUG ELUTING SCAFFOLD

Catalog Number 1012462-28

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Angina (1710)

Event Date 06/02/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The scaffold remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.

Event Description

It was reported that on (b)(6) 2014, the patient underwent a coronary procedure, with implantation of a 2.5 x 28 mm absorb bioresorbable vascular scaffold (bvs) and a 3.5 x 28 mm absorb bvs in the proximal left anterior descending (lad) artery.On (b)(6) 2016, the patient was re-hospitalized with troponin-negative non-cardiac chest pain.Medication was administered on (b)(6) 2016.The patient condition resolved and the patient was discharged on (b)(6) 2016.The patient was referred for outpatient stress echocardiogram; however, the echo window was poor and the physician was unable to see the left ventricle segments.The patient was then referred for cardiac magnetic resonance imaging (mr), which noted normal biventricular size and function and no regional wall motion abnormality.No additional information was provided.

Manufacturer Narrative

(b)(4).Subsequent to the initial 30-day medwatch report, it was noted that this event occurred prior to absorb bioresorbable vascular scaffold (bvs) gt1 approval.At the time of the event, this device was not the same or similar to an approved product; however, this event was filed; therefore, it remains reportable.No investigation is required.

Event Description

Subsequent to the initial 30-day medwatch report, it was noted that this event occurred prior to absorb bioresorbable vascular scaffold (bvs) gt1 approval.At the time of the event, this device was not the same or similar to an approved product; however, this event was filed; therefore, it remains reportable.No additional information was provided.

• Brand Name: ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Type of Device: BIORESORBABLE DRUG ELUTING SCAFFOLD
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7132271
• MDR Text Key: 95315086
• Report Number: 2024168-2017-09954
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2015
• Device Catalogue Number: 1012462-28
• Device Lot Number: 4032161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 103