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

Catalog Number 1234250-28

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

Patient Problems Angina (1710); Arrhythmia (1721); Myocardial Infarction (1969); Stenosis (2263)

Event Date 10/04/2016

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 on (b)(6) 2015, the patient presented with an acute non-st elevated myocardial infarction (stemi).A 2.5x28mm absorb bioresorbable vascular scaffold (bvs) gt1 was successfully implanted in the distal left anterior descending (lad) coronary artery lesion.On (b)(6) 2016, the patient started experiencing chest pain and was admitted to the hospital.Medication was given and a new stemi was diagnosed.50-94% scaffold restenosis was noted in the distal lad.Another percutaneous intervention (pci) was attempted; however was abandoned due to high risk thrombus displacement.There was no additional information provided.

Manufacturer Narrative

(b)(4).There was no reported device malfunction and the product was not returned as the scaffold remains in the anatomy.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 and restenosis, as listed in the absorb gt1 instructions for use, is a known adverse event associated with the use of a coronary scaffold in native coronary arteries.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 there is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

Manufacturer Narrative

Internal file number - (b)(4).(b)(4).A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.It should be noted that the reported patient effect of arrhythmia, 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 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.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

Event Description

Subsequent to the previously filled medwatch report, additional information obtained: during the (b)(6) 2016 hospitalization and during the treatment percutaneous coronary intervention, the thrombus was in the left circumflex (lcx).Post treatment procedure, the patient developed atrial tachyarrythmias, treated with medications.The patient also developed pulmonary edema treated with medication.

Manufacturer Narrative

Internal file number - (b)(4).On (b)(6) 2016, the patient started experiencing chest pain and was subsequently admitted to the hospital with unstable cardiac chest pain, hypoxemia, and bilateral pleural effusions.Elevated cardiac enzymes were noted.Imaging was performed and stent thrombosis was observed in an unspecified stent.There was no scaffold thrombosis observed.Congestive heart failure, severe left ventricular and right ventricular systolic dysfunction was also diagnosed.Per echocardiogram, the patients ejection fraction was 30-35%.Reportedly, the patient has poor compliance with medications.Per physician, the poor compliance is thought to be the main contributor to the patients presentation and the (b)(6) 2016 event was unrelated to the scaffold and unrelated to the scaffold procedure.Medications were provided.Follow-ups will be performed to ensure medication compliance and the event resolved.

Event Description

Subsequent to the previous medwatch report, the additional information was received: on (b)(6) 2016, the patient presented with chest pain radiating to both arms and elevated troponin.Per imaging, the mid rca contained 90% stenosed lesion, the mid lad had moderate disease, and the mid left circumflex was occluded.Another percutaneous intervention (pci) performed in the mid circumflex (cx) coronary artery lesion placing 2 stents.Per physician, the (b)(6) 2016 event was unrelated to the scaffold and unrelated to the scaffold procedure.Regarding the previously reported (b)(6) 2016 event, the chest pain, stemi with hospitalization, and elevated cardiac labs, although per physician, this event is unrelated to the scaffold and unrelated to the scaffold procedure, scaffold restenosis was specified.

• 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: 6183541
• MDR Text Key: 62677897
• Report Number: 2024168-2016-08999
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2016
• Device Catalogue Number: 1234250-28
• Device Lot Number: 5031161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2015
• 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; Disability
• Patient Age: 59 YR
• Patient Weight: 81