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

Catalog Number 1234350-12

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

Patient Problems Cardiac Arrest (1762); Non specific EKG/ECG Changes (1817); Thrombosis (2100)

Event Date 11/15/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During the second week of (b)(6), the patient required another reanimation.Due to the patients severe state of health post multiple thrombotic closures of the absorb gt1 scaffold and four reanimations, the patient will be sent to a neurophysiological rehabilitation for monitoring after their release from intensive care.A defibrillator is in discussion.No additional information was provided.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.A cine was received and reviewed by an abbott vascular clinical specialist.The reviewer concluded: the patient entered the cath lab with angiographically documented thrombosis of proximal lad.Following pre-dilatation the absorb gt1 was deployed at high pressure (19 atm).Subsequent images after post dilatation document what appears to be the presence of residual thrombus at the site of implant.The reported patient effects of cardiac arrest and thrombosis, as listed in the absorb gt1 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 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 on (b)(6) 2016 the patient presented with acute coronary syndrome.The proximal left anterior descending (lad) artery was fully closed with thrombosis.A 3.0 mm trek was used for predilatation with the residual stenosis reduced to less than 40%.A 3.5x12mm absorb gt1 was implanted with 19 atmospheres (atm) of pressure.Post-dilatation was done with a 3.5x8mm nc trek with 22 atm.The final angiographic residual stenosis was greater than 10%.Post procedure 15,000 units of heparin was administered after acute coronary treatment, no prasugrel.Moderate outcome, no intravascular ultrasound (ivus) was done.Thirty minutes after the procedure, the patient showed st elevations on the electrocardiogram and subsequently thrombosis in the absorb gt1 scaffold was identified.Predilatation was performed in the scaffold with a 4.0 nc trek balloon again, ivus control was done and integrelin was administered.The vessel was reopened and flow restored.As the thrombosis occurred 30 minutes after the index procedure the patient had only been given heparin.No prasugrel had been administered.Ninety minutes later after re-procedure, reanimation was necessary because the patient had developed in-scaffold thrombosis again.A 4.0 mm nc trek was used for predilatation in the scaffold area.A 3.5x18 mm xience prox was then placed successfully in the scaffold area.Ivus control was done.Patient still remains in the intensive-care unit with trachectomy, high risk of death, and unable to communicate.

• 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: 6191350
• MDR Text Key: 62910936
• Report Number: 2024168-2016-09060
• Device Sequence Number: 1
• Product Code: PNY
• UDI-Device Identifier: 08717648212864
• UDI-Public: (01)08717648212864(17)170503(10)6050461
• 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
• Report Date: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/03/2017
• Device Catalogue Number: 1234350-12
• Device Lot Number: 6050461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2016
• 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): Hospitalization; Life Threatening; Required Intervention