MAUDE Adverse Event Report: ABBOTT VASCULAR ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE SCAFFOLD

Catalog Number UNK ABSORB

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event, implant date: dates estimated.Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated.The device was not returned for evaluation.A review of the lot history record and complaint history could not be conducted because the part and lot numbers were not provided.Based on the information reviewed, a conclusive cause for the reported difficulties could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional adverse patient effects referenced are being filed under a separate medwatch report #.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the u.S.Article titled: "serial baseline, 12-, 24-, and 60-month optical coherence tomography evaluation of st segment elevation myocardial infarction patients treated with absorb bioresorbable vascular scaffold"na.

Event Description

It was reported through a research article identifying absorb bioresorbable scaffolds that may be related to the following: stent malposition, stenosis, thrombosis, and target vessel revascularization.Details are listed in the article, titled "serial baseline, 12-, 24-, and 60-month optical coherence tomography evaluation of st segment elevation myocardial infarction patients treated with absorb bioresorbable vascular scaffold".

• Brand Name: ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Type of Device: BIORESORBABLE SCAFFOLD
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 12321622
• MDR Text Key: 266623500
• Report Number: 2024168-2021-07162
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): Y
• Reporter Country Code: PL
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ABSORB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR