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

Catalog Number 1235350-12

Device Problems Difficult or Delayed Positioning (1157); Device Damaged by Another Device (2915); Material Deformation (2976)

Patient Problems Angina (1710); Cardiac Enzyme Elevation (1838)

Event Date 04/18/2017

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) 2017, following pre-dilatation, a 3.5x12mm absorb bioresorbable vascular scaffold (bvs) gt1 was implanted in the left anterior descending (lad) lesion.Following, optical coherence tomography (oct) was performed and scaffold deformation was noted.Per physician, the endoscope had interacted with the implanted scaffold.Post dilatation was performed; however, the scaffolds proximal edge (about 4mm distal from the edge) remained lifted.An endoscope failed to cross the lesion so the guideliner was advanced to the middle of the scaffold for visualization.This procedure was completed.Post procedure it was determined to perform another percutaneous intervention as treatment for the deformed scaffold.A 4.0x15mm xience alpine stent was implanted and post-dilatation was performed as treatment.Good wall apposition was observed and the second procedure was completed.Reportedly, the second procedure was performed for 2 hours.Approximately 4 hours post-procedure, the patient experienced chest pain.Coronary angiography found nothing abnormal.Troponin was elevated over 5 times the normal upper limit.The event resolved and on (b)(6) 2017, the patient was discharged from the hospital.There was no additional information provided regarding this device issue.

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents from this lot.It should be noted that the reported patient effect of angina, 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.The investigation determined the reported difficulties, patient effects and treatment are related to circumstances of the procedure as the endoscope likely interacted with the implanted scaffold causing damage resulting in the reported patient effects and additional treatment.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Subsequent to the previously filed medwatch report filed, the additional information was received: on (b)(6) 2017, the 3.5x12mm absorb bioresorbable vascular scaffold (bvs) gt1 was initially implanted without issue and was well apposed to the vessel wall.Following the second percutaneous intervention (pci), the patient experienced chest pain and elevated troponin was noted.The physician considered the elevation as within the range of change affected by ordinal pci.There was no treatment provided, there was no myocardial infarction diagnosed, and the event did not require prolonged hospitalization.

• 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: 6563342
• MDR Text Key: 75035214
• Report Number: 2024168-2017-04106
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 07/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2017
• Device Catalogue Number: 1235350-12
• Device Lot Number: 6100661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2017
• 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
• Treatment: OPTICAL COHERENCE TOMOGRAPHY ENDOSCOPE
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 66