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

Catalog Number 1012464-12

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

Patient Problems Myocardial Infarction (1969); Thrombosis (2100)

Event Date 11/07/2016

Event Type  Injury  

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.The scaffold remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the patient presented with chronic stable angina.The procedure on (b)(6) 2014 was to treat a lesion located in the mid left anterior descending (lad) artery with 80% stenosis.The lesion was prepped with a 3.5x10 mm scoring balloon catheter at 10 atmospheres (atm).The residual stenosis was reduced to less than 40% after pre-dilatation.A 3.5x12 mm absorb was implanted and post-dilatated with a 4.0x10 mm non-abbott balloon catheter at 10 atm.Optical coherence tomography was used to confirm the scaffold was fully apposed to the vessel wall.The final angiographic residual stenosis was less than 10%.The patient was placed on dual anti-platelet therapy (dapt).Clopidogrel was stopped in (b)(6) 2015.The patient was switched to falithrom on (b)(6) 2016.Around the first week of (b)(6) 2016, the patient entered the hospital again due to an unrelated operation.Due to this operation, the patient stopped their dapt.On (b)(6) 2016, the patient experienced a sub-acute infarction and in-scaffold thrombosis which was confirmed using oct.The thrombosis was treated with the implantation of a 3.5x15 mm drug eluting stent.Timi iii flow was restored.The patient outcome was good.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.A review of the lot history record and complaint history could not be conducted because the lot number was not provided.A cine of the procedure was received and reviewed by a clinical specialist who concluded the following: in the short cine runs provided, no apparent cause was evident; however, late scaffold thrombosis was confirmed.The reported patient effects of myocardial infarction and thrombosis, 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.

• 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: 6133177
• MDR Text Key: 61057873
• Report Number: 2024168-2016-08398
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1012464-12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2016
• 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
• Patient Outcome(s): Hospitalization; Required Intervention; Disability