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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of event has been estimated.Implant date has been estimated.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.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 procedure was to treat a lesion located in the proximal and distal left anterior descending (lad) artery.Two absorb scaffolds were implanted approximately 3.5 years ago.The patient returned to the cath lab due to symptomatic chest pain, not sure whether this was a stemi or elective admission.The angiogram diagnostic showed no cause for concern in any of the arteries, but it was decided to perform coronary optical frequency domain imaging of the two scaffolds.In a few frames of the images `struts' still appeared present on the surface of the vessel wall of the proximal segment of the proximal scaffold.The patient was started on dual anti-platelet therapy again, due to the absence of healing, and risk of a thrombotic response to the struts location.The patient has suffered no major complication and the chest pain was not related to the appearance of the absorb scaffold.No additional information was provided.

Manufacturer Narrative

(b)(4).The udi is unknown because the part number and lot number were not provided.The device was not returned for evaluation.A review of the lot history record and complaint history of the reported device could not be conducted because the part and lot numbers were not provided.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.One cine image was received and reviewed by an abbott vascular clinical specialist.The reviewer noted that it is possible that the original deployment was slightly undersized and left a few struts malapposed contributing to the slow resorption.Also, there appears to be a few remaining struts which are covered with a very shallow tissue layer.These may have originally also been malapposed and healed over much later.The investigation was unable to determine a conclusive cause for the reported slow resorption.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 6191471
• MDR Text Key: 62909541
• Report Number: 2024168-2016-09063
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• 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: 02/02/2017
• 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
• Treatment: OTHER: ABSORB SCAFFOLD
• Patient Outcome(s): Required Intervention