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 12/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Literature attachment: the demise of the absorb bvs: lessons learned from the discontinuation of a disappearing stent.Date of event has been estimated.Date of implant has been estimated.The scaffold remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The additional adverse patient effects referenced in the article are being filed under a separate medwatch report #.

Event Description

It was identified through review of the article that the absorb bioresorbable vascular scaffold (bvs) may be related to under-expansion and mal-apposition of the scaffold.It is unknown what intervention was performed, if any.Details are listed in the article, titled, "the demise of the absorb bvs: lessons learned from the discontinuation of a disappearing stent".

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 numbers 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.Unique device identifier (udi): in the absence of reported part number, udi cannot be calculated.

• 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: 8297628
• MDR Text Key: 134860869
• Report Number: 2024168-2019-00761
• 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: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/07/2019
• Initial Date FDA Received: 02/01/2019
• Supplement Dates Manufacturer Received: 02/11/2019
• Supplement Dates FDA Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1