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

Catalog Number 1012463-28

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

Patient Problems Angina (1710); Stenosis (2263)

Event Date 10/15/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of implant - estimate.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.The device was not returned for evaluation.A review of the lot history record and complaint history could not be conducted because the lot numbers were not provided.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 information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The 3.5 x 28 mm and 3.0 x 12 mm rx absorb devices are being filed under separate manufacturer report numbers.

Event Description

It was reported that the procedure in (b)(6) 2015 was to treat 70% stenosis in the proximal to distal left anterior descending artery.The patient presented with unstable angina.Optical coherence tomography (oct) was done and pre-dilatation was performed prior to implanting 3 absorb scaffolds (3.5x28mm, 3.0x28mm and 3.0x12mm) in the 3 locations.Post-dilatation was performed and oct confirmed good wall apposition and less than 10% residual stenosis.The patient returned less than 6 months after implantation with angina and severe restenosis was found.Drug eluting stents were implanted for treatment.The final outcome was very good and the patient is doing well.It was confirmed that the patient had been compliant with dual antiplatelet drug therapy (dapt) after the procedure.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: 6122899
• MDR Text Key: 60745834
• Report Number: 2024168-2016-08275
• Device Sequence Number: 1
• Product Code: PNY
• UDI-Device Identifier: 08717648157042
• UDI-Public: (01)08717648157042
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1012463-28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: SCAFFOLD: 3.5 X 28 MM AND 3.0 X 12 MM RX ABSORB
• Patient Outcome(s): Hospitalization; Required Intervention