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

Catalog Number 1012462-08

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

Patient Problems Angina (1710); Stenosis (2263)

Event Date 06/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).3.5x12mm and 3.5x18mm absorb bioresorbable vascular scaffold (bvs), aspirin, p2y12 inhibitor medication.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.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 (bvs) system, absorb, instructions for use (ifu), are known adverse events 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 the treatment appears to be related to the circumstances of the procedure.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

Event Description

It was reported that on (b)(6) 2014, a 3.5x12mm and a 3.5x18mm absorb bioresorbable vascular scaffold (bvs) were implanted in the proximal left anterior descending (lad) coronary artery lesion, and a 2.5x8mm bvs was implanted in the 2nd diagonal coronary artery lesion.There was no device malfunction reported.In (b)(6) 2016, the patient expressed experiencing stable angina and imaging was performed.On (b)(6) 2016, another percutaneous procedure was performed due to 70-80% restenosis of the 2.5x8mm bvs implanted in the 2nd diagonal coronary artery lesion.Medications were also provided.There was no additional information provided regarding this issue.

Manufacturer Narrative

(b)(4).

Event Description

Subsequent to the previous medwatch report, the additional information was obtained: the patient started experiencing chest pain on (b)(6) 2016.

• 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: 7220640
• MDR Text Key: 98277623
• Report Number: 2024168-2018-00623
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/21/2018

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: 01/12/2016
• Device Catalogue Number: 1012462-08
• Device Lot Number: 4071761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2018
• Initial Date FDA Received: 01/25/2018
• Supplement Dates Manufacturer Received: 07/31/2018
• Supplement Dates FDA Received: 08/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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: 57 YR
• Patient Weight: 93