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

Catalog Number 1012464-18

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Angina (1710); Thrombosis (2100); Stenosis (2263)

Event Date 06/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.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 the procedure on (b)(6) 2016 was to treat a heavily calcified lesion in the distal right coronary artery (rca).The patient presented with st elevated myocardial infarction (stemi).Pre-dilatation was performed with a 3.0 x 12 mm non-compliant balloon.A 3.5 x 18 mm absorb scaffold was implanted and post-dilated with a 4.0 x 15 non-compliant balloon.Final angiographic residual stenosis was less than 10%.On (b)(6) 2017, the patient returned with mild chest pain.The patient had stopped their dual antiplatelet drug therapy (dapt) 48 hours prior.Optical coherence tomography (oct) was performed which identified thrombosis at the proximal end of the scaffold, which appeared under-expanded.Restenosis was observed the length of the scaffold.There were malapposed struts at the distal end of the scaffold.A 3.5 x 38 mm non-abbott drug eluting stent (des) was implanted and post-dilated at high pressure.Oct was performed which showed good apposition of the des, but also showed that some struts appeared to have been sheered off and were now located in the distal rca.The patient is asymptomatic.No additional intervention was performed; however, the decision was made to keep the patient on long term dapt.No additional information was provided.

Manufacturer Narrative

(b)(4).Correction: patient code (b)(4) was removed.The product was not returned as the scaffold remains in the patient.Cine films and optical coherence tomography (oct) were received and reviewed by an abbott vascular physician.The reviewer concluded the following: there was satisfactory initial index implantation of the absorb scaffold with adequate size device and adequate size post-dilatation balloon.The restenosis approximately 9 months post-implant is a combination of under-expanded scaffold and neointimal hyperplasia, but is focal and flow was well-preserved with no thrombosis.The restenosis was successfully treated with metallic stents.Oct images show the restenosis and intra-luminal disrupted struts distal to the metallic stents after they were placed for the restenosis.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 angina and restenosis, 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.The investigation determined the reported difficulties and patient effects appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

A cine of the procedures was returned and reviewed by an abbott vascular physician.The reviewer confirmed restenosis; however, there was no evidence of thrombosis.

• 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: 6675728
• MDR Text Key: 78654612
• Report Number: 2024168-2017-05506
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1012464-18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2017
• 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