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

Catalog Number 1012462-18

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

Patient Problems Angina (1710); Arrhythmia (1721); Dyspnea (1816); Cardiac Enzyme Elevation (1838); Stenosis (2263)

Event Date 12/28/2015

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.

Event Description

It was reported that on (b)(6) 2014, the patient underwent a coronary procedure, with implantation of a 2.5 x 18 mm absorb bioresorbable vascular scaffold (bvs) in the mid left anterior descending (lad) artery.On (b)(6) 2015, the patient had complaints of angina.Troponin levels were negative and the patients cholesterol medication, atorvastatin, was changed to rosuvastatin.The patient was referred to a rapid access chest pain clinic and the event resolved on (b)(6) 2015.On (b)(6) 2016, the patient had complaints of angina and medications were administered.Troponin levels were negative and the event resolved on (b)(6) 2016.The patient experienced angina on (b)(6) 2016.Medications were administered as treatment.Troponin levels were negative and the patient was diagnosed with anxiety.The patient was referred for coronary angiography.The event continued.On (b)(6) 2016, the patient underwent coronary angiography, due to multiple events of angina.A minor ostial lesion was noted towards the end of the stented segment, with a small area of minor in-stent restenosis.Medical management will be continued.No additional information was provided.

Manufacturer Narrative

(b)(4).There was no reported device malfunction and the product was not returned as the scaffold remains in the anatomy.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of angina and restenosis, as listed in the bioresorbable vascular scaffold system, absorb, instructions for use as a known adverse event associated with the use of a coronary scaffold in native coronary arteries.Based on the case information and related record review, a conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined and there is no indication of a product quality issue with respect to design, manufacture or labeling of the device.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.

Manufacturer Narrative

(b)(4).The reported patient effect of arrhythmia as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use is a known adverse event associated with the use of a coronary scaffold in native coronary arteries.Based on the case information and related record review, a conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined and there is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

Event Description

Subsequent to the initial 30-day and follow-up medwatch reports, the following additional information was provided: on (b)(6) 2015, the patient experienced shortness of breath, palpitations and enzyme elevation.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: 7275646
• MDR Text Key: 100233166
• Report Number: 2024168-2018-01169
• 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: foreign,health professional,s
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2015
• Device Catalogue Number: 1012462-18
• Device Lot Number: 4030461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2018
• 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): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 100