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 Cardiac Arrest (1762); Death (1802); Myocardial Infarction (1969); Thrombosis (2100); Ventricular Tachycardia (2132); Stenosis (2263)

Event Date 03/25/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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.Cine films were received and reviewed by an abbott vascular clinical specialist.The reviewer concluded the following: single vessel disease is treated with absorb scaffold implantation with no pre-dilatation or post-dilatation.After expansion the distal scaffold is underexpanded.One year post implant under expansion persists.The patient returns at 22 months post implant and one month after stopping aspirin with thrombus in the vessel proximal to the scaffold extending into the proximal scaffold.There appears to lesion progression in the mid distal of the scaffold extending distally.A metallic stent is seen in the vessel distal to the scaffold.Implantation is not documented.Thrombus is seen throughout the proximal to mid vessel and continues to occlude the distal vessel.The reported patient effects of cardiac arrest, death, myocardial infarction, thrombosis 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.Additionally, the ifu states: pre-dilate the lesion with a percutaneous transluminal coronary angioplasty catheter.It is unknown if the reported ifu deviation caused or contributed the reported complaint.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.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.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 the procedure on (b)(6) 2015 was performed at (b)(6) hospital the patient presented with atrial fibrillation and ventricular tachycardia.The patient was given flecaine and bisorpolol.A 3.5 x 28 mm absorb scaffold was implanted in a 70-90% stenosis in the mid left anterior descending artery.Vessel size 3.5mm with timi 3 flow.Pre-dilatation and post-dilatation was not performed.No imaging was done.The patient was prescribed xarelto (due to rythym issues) and aspirin.A control angiogram was performed in (b)(6) 2016 with a good result.The patient was re-hospitalized (b)(6) 2016 due to prolonged chest pain.Angiography was done (b)(6) 2016 and showed no restenosis in the scaffold.On (b)(6) 2017, the rythmolog physician recommended to stop aspirin and increased dosage of xeralto.On (b)(6) 2017 the patient had a massive myocardial infarction and cardiac arrest and was admitted to montlucon hospital.Angiography noted long acute occlusions (restenosis) at the proximal and mid lad.Three non-abbott drug eluting stents were implanted for treatment.The patient died 24 hours later with severe ventricular tachycardia and ischemic disease.Vessel thrombosis was suspected.No autopsy was performed.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: 6513056
• MDR Text Key: 73405904
• Report Number: 2024168-2017-03483
• Device Sequence Number: 1
• Product Code: PNY
• UDI-Device Identifier: 08717648157127
• UDI-Public: (01)08717648157127(17)151020(10)4102161
• 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: 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/20/2015
• Device Catalogue Number: 1012464-28
• Device Lot Number: 4102161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2017
• 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): Death
• Patient Age: 68 YR