MAUDE Adverse Event Report: AV-TEMECULA-CT ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE DRUG ELUTING SCAFFOLD

Catalog Number 1235300-28

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

Patient Problems Angina (1710); Death (1802); Myocardial Infarction (1969); Stenosis (2263); Respiratory Failure (2484)

Event Date 05/17/2017

Event Type  Death  

Manufacturer Narrative

The patient and device codes in f10 were coded by the manufacturer.(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 coronary artery disease and an acute anterior wall myocardial infarction (awmi).The procedure on (b)(6) 2016 was to treat a lesion in the left anterior descending (lad) and left circumflex (cx) with moderate tortuosity, moderate calcification and 90% stenosis.Vessel sizing was done with intravascular ultrasound (ivus) with the vessel diameter determined to be greater than 2.5mm.A semi-compliant balloon was used for lesion preparation with residual stenosis reduced to less than 40%.A 3.0x28mm absorb gt1 scaffold was implanted and post-dilatation performed with a non-compliant balloon.The final angiographic residual stenosis was less than 10%.Ivus was performed to confirm that the scaffold was fully apposed to the vessel wall.The patient returned on (b)(6) 2017 with chest pain and awmi and subsequently restenosis was identified.The patient was intubated and a loading dose of ticagrelor was given.The restenosis was treated with the implantation of a non-abbott stent placed in the left main to lad; however, the patient condition was critical and the patient died on (b)(6)2017.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of angina, myocardial infarction, restenosis and death, as listed in the bioresorbable vascular scaffold (bvs) system, absorb gt1 instructions for use, are known adverse events associated with the use of a coronary scaffold in native coronary arteries.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 the design, manufacture, or labeling of the device.

Event Description

Subsequent to filing the initial mdr, the following information was received: the patient was confirmed to have been compliant with their dual anti-platelet therapy.

• Brand Name: ABSORB GT1 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: 6634963
• MDR Text Key: 77379181
• Report Number: 2024168-2017-04979
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2018
• Device Catalogue Number: 1235300-28
• Device Lot Number: 6101461
• 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: 10/01/2016
• 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