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

Device Problems Material Too Rigid or Stiff (1544); Improper or Incorrect Procedure or Method (2017)

Patient Problems Myocardial Infarction (1969); Thrombosis (2100)

Event Date 12/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Device code 2017 - failure to follow steps/instructions (poor implantation technique and inadequate sizing referenced in the article.) age: mean age.Gender: majority of patients were male.Date of event: estimated date.Udi #: udi is listed as unk because the part and lot numbers were not provided.Implant date: estimated date.Article titled: three to four years outcomes of the absorb bioresorbable vascular scaffold versus second-generation drug-eluting stent: a meta-analysis.The device was not returned for evaluation.A review of the electronic lot history record (elhr) for this product was not performed because the part and lot numbers were not reported and the product was not returned for analysis.The reported potential adverse events of myocardial infarction and thrombosis are listed in the absorb gt1 bioresorbable vascular scaffold (bvs) system instructions for use as known adverse events that may be associated with treatment procedures and the use of coronary scaffold.It was reported that the implantation technique (adequate pre-dilation with a non-compliant balloon, implantation after confirmation of adequate pre-dilations, and post-dilation with a non-compliant balloon), and inadequate sizing were factors in the increase risk for the reported patient effects.It should be noted that the absorb gt1 bioresorbable vascular scaffold (bvs) system, electronic ifu, states: implantation of the device in vessels < 2.5 mm may lead to an increased risk of adverse events such as myocardial infarction and scaffold thrombosis.Pre-dilate the lesion to match the reference vessel diameter with a percutaneous transluminal coronary angioplasty catheter.Pre-dilatation should be performed with an angioplasty balloon which can also be utilized to properly size the vessel.Post-dilatation is strongly recommended for optimal scaffold apposition.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 manufacture, design or labeling.The xience device referenced is being filed under a separate medwatch report #.The additional adverse patient effect of death referenced is being filed under a separate medwatch report #.

Event Description

It was reported through a research article identifying the absorb scaffold and xience drug eluting stent that may be related to a cardiac mortality, myocardial infarction, revascularization, and thrombosis.Details are listed in the article, titled, three to four years outcomes of the absorb bioresorbable vascular scaffold versus second-generation drug-eluting stent: a meta-analysis by goel et al.

Manufacturer Narrative

During processing of this complaint, attempts were made to obtain complete event, patient and device information.Correction: conclusion code 4311 removed and conclusion code 18 added.Internal file number - (b)(4).

• 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: 8684898
• MDR Text Key: 147524663
• Report Number: 2024168-2019-04555
• 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: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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): Hospitalization; Required Intervention; Disability
• Patient Age: 63 YR