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

Catalog Number 1235300-23

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

Patient Problems Non specific EKG/ECG Changes (1817); Thrombosis (2100)

Event Date 12/10/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The 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 effect of thrombosis, as listed in the absorb gt1 instructions for use (ifu), is a known adverse event 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 and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.

Event Description

It was reported that the patient presented with a st-elevated myocardial infarction (stemi).The procedure was to treat a de novo lesion located in the proximal left anterior descending (lad) artery.The vessel was determined to be greater than 2.5 mm in diameter.Predilatation was performed with a non-abbott balloon catheter with the residual stenosis reduced to less than 40%.A 3.0 x 23 mm absorb gt1 scaffold was deployed and post-dilatation was performed with a 3.5 x 12 non-abbott balloon catheter at 12 atmospheres (atm).The final angiographic residual stenosis was less than 10%.The absorb gt1 scaffold was not confirmed to be fully apposed to the vessel wall because imaging with intravascular ultrasound or optical coherence tomography was not available in the hospital.Twelve hours after the procedure st elevation was noted and subsequently in-scaffold thrombosis was identified in the absorb gt1 scaffold.The patient was treated with balloon angioplasty.Patient is doing well.It was confirmed that the patient was compliant in following the dual antiplatelet drug therapy (dapt) consisting of clopidogrel after the index procedure.The patients medication was changed from clopidogrel to prasugrel.No additional information was provided.

• 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: 6216061
• MDR Text Key: 63661229
• Report Number: 2024168-2016-09405
• Device Sequence Number: 1
• Product Code: PNY
• UDI-Device Identifier: 08717648213052
• UDI-Public: (01)08717648213052(17)180408(10)6101161
• 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
• Report Date: 12/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/08/2018
• Device Catalogue Number: 1235300-23
• Device Lot Number: 6101161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2016
• 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): Required Intervention