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

Catalog Number 1235250-18

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

Patient Problems Angina (1710); Cardiac Arrest (1762); Death (1802); Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914); Pulmonary Edema (2020); Thrombosis (2100); Cardiogenic Shock (2262); Respiratory Failure (2484)

Event Date 11/03/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).The scaffold remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The 3.0 x 18 mm absorb gt1 is being filed under a separate medwatch report.

Event Description

Patient presented on (b)(6) 2016 with idiopathic ventricular fibrillation with decreased left side function and recent electrophysiology (ep) ablation.It was noted at 2:00 pm that the patient showed no left ventricular function following the ep ablation.A 2.5x18 mm absorb gt1 bioresorbable vascular scaffold (bvs) was implanted in the left anterior descending coronary artery and a 3.0x18 mm absorb gt1 bvs was implanted in the circumflex coronary artery.Both bvs were post-dilated and post procedure the patient was stable.Later that night at 11:20 pm, the patient experienced ekg changes including st elevation, hypotension, angina, and thrombosis.The patient was restarted on integrilin and was sent back to the cath lab.At 12:20 am, angiogram was performed; patient then went into cardiogenic shock and was intubated.The patient was sent into surgery, after 1.5 hour.A balloon pump was inserted at 1:00 am.The patient expired during surgery ((b)(6) 2016, 2:06 am).The official cause of death from the initial coroner report is cardiac arrest.Cardiopulmonary resuscitation was performed, unable to ventilate due to pulmonary edema.As of (b)(6) 2016 an autopsy had not been performed.No additional information was provided.

Manufacturer Narrative

(b)(4).Product performance engineering reviewed the incident information; however, there was no reported device malfunction and the product was not returned as the scaffold remains in the anatomy.The cine of the event was received and reviewed by an abbott clinical specialist who concluded the following: acute thrombosis of the double barrel simultaneous kissing scaffolds in the left main (lm) due to severe under-expansion, and actual compression of one of the scaffolds, in a very high risk complex lm bifurcation lesion involving both the left anterior descending (lad) artery and the left circumflex (lcx), in the setting of a very unstable clinical status due to refractory ventricular fibrillation on initial presentation pre-scaffolds.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 and the treatment appears to be related to the circumstances of the procedure.It should be noted that the reported patient effects of angina, cardiac arrest, death, hypotension, thrombosis and shock, are listed in the absorb gt1 instructions for use, as known adverse events associated with the use of a coronary scaffold in native coronary arteries.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• 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: 6130597
• MDR Text Key: 60988898
• Report Number: 2024168-2016-08386
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2017
• Device Catalogue Number: 1235250-18
• Device Lot Number: 6051061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2017
• 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
• Treatment: SCAFFOLD: 3.0 X 18 MM ABSORB GT1
• Patient Outcome(s): Death
• Patient Age: 18 YR
• Patient Weight: 86