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

Catalog Number 1012464-23

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

Patient Problems Angina (1710); Cardiac Enzyme Elevation (1838); Stenosis (2263)

Event Date 10/31/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: absorb bvs 3.0x28mm, 3.5x18mm, and 3.5x12mm.The scaffold remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6) 2015, a 3.0x28mm absorb bioresorbable vascular scaffold (bvs) was successfully implanted in the mid left anterior descending (lad) artery and 3.5x23mm, 3.5x18mm, and 3.5x12mm scaffolds were successfully implanted in the proximal lad.On (b)(6) 2016, the patient was admitted to the hospital for unstable angina following exertion, lasting several minutes.The angina improved with nitroglycerine spray.Slightly elevated troponin was noted and no ischemic changes were observed per electrocardiogram.Another percutaneous intervention was performed via balloon angioplasty in the proximal left anterior descending (lad) coronary artery severely restenosed lesion, and in the diagonal coronary artery ostium.Per physician, the event was unrelated to the implanted scaffolds and unrelated to the index procedure.Reportedly, there are concerns if the patient is complaint with dual antiplatelet therapy (dapt).The event resolved without sequela.There was no additional information provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.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 (bvs) system, absorb, instructions for use (ifu), are 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.

• 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: 6337847
• MDR Text Key: 67649659
• Report Number: 2024168-2017-01280
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2015
• Device Catalogue Number: 1012464-23
• Device Lot Number: 4102061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2017
• Initial Date FDA Received: 02/16/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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: 56 YR
• Patient Weight: 90