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

Catalog Number 1012464-28

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

Patient Problems Aneurysm (1708); Perforation (2001)

Event Date 07/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Describe event or problem continued: intravascular ultrasound showed intimal dissection due to the cutting balloon and intrastent hematoma of the pcs, which extended distally but stopped at the lesion with aneurysm due to absence of neointima on malapposed metal struts.The intimal dissection was treated with implantation of a 3.5x24-mm non-abbott stent.The hematoma stopped at the lesion with aneurysm due to absence of neointima on malapposed pcs metal struts.Final intravascular ultrasound confirmed complete lesion sealing of dissection and hematoma.See attached article for additional details.Concomitant medical products: stent: ultimaster 4.0x18-mm (terumo); other: absorb scaffold x2.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

The following information was reported through a research article titled: intrastent hematoma after pre-dilatation for 17-month restenosis of polytetrafluoroethylene-covered stent it was reported that the procedure was to treat the proximal right coronary artery (rca) with a chronic total occlusion.Three absorb bioresorbable vascular scaffolds (bvs) were implanted in the distal to proximal right coronary artery (rca) and a 4.0x18mm non-abbott stent implanted in the ostium.Post implantation, an ellis type 3 coronary perforation was observed which was treated with a 4.0x18-mm polytetrafluoroethylene-covered (pcs) non-abbott stent.Follow-up coronary angiography 17 months later showed a patent rca, aneurysmal changes in the proximal segment (3.5x28mm absorb), and focal restenosis of the pcs in the ostium.Therefore, percutaneous coronary intervention was attempted.The lesion was prepared with a 3.5-mm cutting balloon, following which the patient experienced chest pain with inferior st segment elevation on electrocardiography.Coronary angiography revealed critical in-stent narrowing of the pcs extended distally to the initial lesion which was dilated with a 2.5-mm semi-compliant balloon (8 atm), with rapid symptom and electrocardiography resolution.

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 and complaint history of the reported device could not be conducted because the lot number was not provided.The reported patient effects of aneurysm and perforation, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use are known adverse events associated with the use of a coronary scaffold in native coronary arteries.Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• 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: 7130756
• MDR Text Key: 95321416
• Report Number: 2024168-2017-09907
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/10/2018

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 Catalogue Number: 1012464-28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2018
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR