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

Catalog Number 1012462-12

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Angina (1710); Stenosis (2263); Test Result (2695)

Event Date 06/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation, as the scaffold remains in the patient.A cine was received and reviewed by an abbott vascular clinical specialist.The reviewer confirmed the restenosis in mid left anterior descending (lad) approximately 2 years following absorb scaffold implantation which was successfully treated with a metallic drug eluting stent.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other similar incidents from this lot.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 difficult to deploy (wall apposition) appears to be related to circumstances of the procedure.Additionally, it is possible the reported patient effects are related to the difficulty deploying the scaffold (wall apposition).There is no indication of product quality issue with respect to the design, manufacture or labeling of the device.There is no indication of product quality issue with respect to the 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.

Event Description

It was reported that the procedure on (b)(6) 2015 was to treat a 90% - 99% sub-occlusive stenosis in the mid left anterior descending (lad) artery.The patient had been experiencing unstable angina and had a positive stress test.Pre-dilatation was performed with a 2.5 x 15 mm trek balloon and a 2.5 x 12 mm absorb scaffold was implanted.Post-dilatation was done with the 2.5 x 15 mm trek balloon with a final residual stenosis less than 10%.There was no intravascular ultrasound or optical coherence tomography used during this procedure.On (b)(6) 2017, the patient experienced unstable angina and had a positive stress test.A new procedure was performed and a 90% - 99% restenosis was observed in the scaffold as well as a bad wall apposition.Reference diameter was 3 mm.A significant stenosis was also observed in the 2nd diagonal.The restenosis was treated with a 3.0 x 20 mm non-abbott drug eluting stent.The outcome was good with no residual stenosis and a timi 3 flow.It was further reported that the patient had been on dual antiplatelet drug therapy (dapt) of plavix and aspirin for 1 year after the initial procedure, but then was on plavix only.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: 6719982
• MDR Text Key: 80247202
• Report Number: 2024168-2017-05948
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2015
• Device Catalogue Number: 1012462-12
• Device Lot Number: 4103062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2017
• 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: 52 YR