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

Catalog Number UNK ABSORB

Device Problem Break (1069)

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

Event Date 01/01/2017

Event Type  Injury  

Event Description

It was reported through a research article, identifying an unknown absorb bio-resorbable vascular scaffold (bvs) system as follows: post-procedural intravascular imaging was used in this reported case of perforation complicating the absorb bio-absorbable vascular scaffold (bvs) implantation.In this cases, adequate stent apposition was confirmed.However, the physician observed, a stent fracture of the bvs at both the time of implantation and again at the 1 month follow up.A drug eluting stent (des) was implanted over the bvs.The above statement was noted in the article, titled coronary artery perforation after bio-resorbable scaffold implantation treated with a new generation covered stent¿ oct insights.

Manufacturer Narrative

Date of event - estimated.The unique device identifier (udi) is unknown because the part number and lot number were not provided.Date of implant ¿ estimated.The device was not returned for analysis.A review of the electronic lot history record (elhr) and similar incident query for this product was not performed because the part and lot numbers were not reported and the product was not returned for analysis.Based on the information reviewed, a conclusive cause for the reported difficulties could not be determined.The treatment appears to be related to the circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.Literature.Article title ¿coronary artery perforation after bioresorbable scaffold implantation treated with a new generation covered stent¿oct insights.".

• 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: 13877825
• MDR Text Key: 288368149
• Report Number: 2024168-2022-03086
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): Y
• Reporter Country Code: AS
• 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: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• 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: 02/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention