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

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

Patient Problems Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Occlusion (1984); Thrombosis (2100); Stenosis (2263)

Event Date 02/01/2019

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, implant date: estimated dates.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the u.S.Product performance engineering reviewed the incident information; however, there was no reported device malfunction and the product was not returned.A review of the lot history record and complaint history could not be conducted because the part and lot number were not provided.The reported patient effects of occlusion 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.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.The unk xience device referenced is being filed under a separate medwatch report.Literature: "clinical outcomes at 2 years of the absorb bioresorbable vascular scaffold versus the xience drug-eluting metallic stent in patients presenting with acute coronary syndrome versus stable coronary disease - aida trial sub-study.".

Event Description

It was reported through a research article that absorb bioresorbable vascular scaffold stents and xience drug-eluting stents may be related to thrombosis and target vessel failure [occlusion].Specific patient information is documented as unknown.Details are listed in the article, title: "clinical outcomes at 2 years of the absorb bioresorbable vascular scaffold versus the xience drug-eluting metallic stent in patients presenting with acute coronary syndrome versus stable coronary disease - aida trial sub-study.".

Manufacturer Narrative

Internal file number: (b)(4).Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated.Product performance engineering reviewed the incident information; however, there was no reported device malfunction and the product was not returned as the scaffold remains in the anatomy.Based on the information reviewed, a conclusive cause for the reported patient effects could not be determined, however the reported scaffold discontinuities 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.

Manufacturer Narrative

Patient codes: 1888 labeled 2263 labeled 1969 labeled.Internal file number - (b)(4).Correction: outcomes attribute to adverse event.The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Attachment: article.Clinical outcomes at 2 years of the absorb bioresorbable vascular scaffold versus the xience drug-eluting metallic stent in patients presenting with acute coronary syndrome versus stable coronary disease - aida trial sub-study.

Event Description

Subsequent to the initially filed report, the following information was received via a full version of the research article: absorb bioresorbable vascular scaffold stents may also be related to hemorrhage, stenosis and myocardial infarction.The thrombosis previously reported in absorb bioresorbable vascular scaffold stents may occur due to the scaffold dismantling.Additionally xience drug-eluting stents may be related to vessel inflammation, stenosis and myocardial infarction.Details are listed in the attached article, title "clinical outcomes at 2 years of the absorb bioresorbable vascular scaffold versus the xience drug-eluting metallic stent in patients presenting with acute coronary syndrome versus stable coronary disease - aida trial sub-study".

• 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: 8383275
• MDR Text Key: 137588924
• Report Number: 2024168-2019-01600
• 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,Followup
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 64 YR