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

Catalog Number 1234350-28

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problem Thrombosis (2100)

Event Date 09/28/2016

Event Type  Injury  

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.

Event Description

It was reported that the index procedure on (b)(6) 2016 was performed at (b)(6) hospital.The patient presented with st elevated myocardial infarction.A thrombotic occlusion was found in the mid right coronary artery (rca).Pre-dilatation was not performed.A 3.5 x 28 mm absorb gt1 scaffold was deployed and post-dilated with a 3.75 x 15 mm balloon up to 25 atmospheres (atm) and a 4.0 x 12 mm balloon up to 18 atm.Residual stenosis was less than 10%.Nine hours after the procedure the patient had ventricular fibrillation (vf) and cpr was performed.The patient was transferred to (b)(6) hospital where catheterization showed scaffold thrombosis and an urgent thrombectomy was performed.The patient was admitted to the intensive care unit and three days later suffered another episode of vf.Optical coherence tomography (oct) showed a broken scaffold strut; therefore, a xience stent was implanted.It was confirmed that the patient had been compliant with dual antiplatelet drug therapy (dapt).The patient remained hospitalized, but was discharged on (b)(6) 2016 with new york heart association (nyha) class 1 and left ventricular ejection fraction 45%.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.The reported patient effects of thrombosis and ventricular fibrillation, 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.It should be noted that the ifu states: pre-dilate the lesion to match the reference vessel diameter with a percutaneous transluminal coronary angioplasty catheter.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The investigation was unable to determine a conclusive cause for the reported stent break and patient effects.

• 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: 6073720
• MDR Text Key: 59010246
• Report Number: 2024168-2016-07496
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 11/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: 1234350-28
• Device Lot Number: 6060161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• 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; Required Intervention