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

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem Myocardial Infarction (1969)

Event Date 01/14/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of event: estimated.In the absence of a reported part number, the udi cannot be calculated.Implant date: estimated.The device was not returned for evaluation.A review of the lot history record and complaint history of the reported devices could not be conducted because the part and lot numbers were not provided.The reported patient effects of myocardial infarction and thrombosis, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use are known adverse events associated with the use of a coronary scaffold in native coronary arteries.The investigation was unable to determine a conclusive cause for the reported scaffold malposition and patient effects.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the u.S.Literature attachment: an observational study of clinical outcomes of everolimus-eluting bioresorbable scaffolds comparing the procedural use of optical coherence tomography against angiography alone.

Event Description

It was reported through an article identifying absorb bioresorbable vascular scaffolds (bvs) that may be related major adverse cardiac events, recurrent myocardial infarction, target revascularization, stent thrombosis due to scaffold malposition.No additional information was provided.

• Brand Name: ABSORB 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: 7455170
• MDR Text Key: 106316031
• Report Number: 2024168-2018-03012
• 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: literature
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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