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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2018

Event Type  malfunction  

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 based on date of article publication.Date of implant has been estimated based on date of first patient enrollment.Alert date has been estimated based on date the article was read.The scafold remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Literature: angiographic and midterm outcomes of bioresorbable vascular scaffold for coronary bifurcation lesions.Author- pieter smits, american journal of cardiology 122.12: 2035-2042.Elsevier inc.(dec 15, 2018).The additional adverse patient effects and patient deaths referenced in the article are being filed under separate medwatch report #s.

Event Description

It was reported through a data review of 107 patients between july 2009 and december 2015 identifying absorb bioresorbable vascular scaffolds (bvs) that may be related to malapposed scaffold struts.Article titled "angiographic and midterm outcomes of bioresorbable vascular scaffold for coronary bifurcation lesions".

Manufacturer Narrative

Internal file number: (b)(4).The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot number were not provided.Based on the information reviewed, a conclusive cause for the reported difficulty to deploy could not be determined.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
• MDR Report Key: 8358101
• MDR Text Key: 136761893
• Report Number: 2024168-2019-01275
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR