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

Catalog Number 1012462-18

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2017

Event Type  Injury  

Manufacturer Narrative

Date of event: estimated.Date of implant: estimated.The device was not returned for analysis.A review of the lot history record and complaint history could not be conducted because the lot number was not provided.The patient effects/treatments listed are consistent with the product risk profile and are therefore expected.Factors that may contribute to the performance outcomes listed in the article include, but are not limited to, device to patient interaction, patient anatomical conditions, device to user interaction and manufacturing or material issues.Due to the limited information available, the exact root cause cannot be determined.A conclusive cause for the difficulties listed can not be determined based on the limited information available.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.Article title "one-year results following a pre-specified absorb implantation strategy in st-elevation myocardial infarction (bvs stemi strategyit study)".The other events listed in the article are reported under different mfr report numbers.

Event Description

It was reported through a research article identifying the absorb bioresorbable vascular scaffold (bvs) may be related to the following: after pre-dilatation of the lesion in the mid left anterior descending artery, a 2.5x18mm absorb scaffold was implanted but was not post dilated.Ten months' post implant, target lesion re-vascularization was performed via elective percutaneous coronary intervention with implantation of a drug eluting stent.Details are listed in the attached article, titled "one-year results following a pre-specified absorb implantation strategy in st-elevation myocardial infarction (bvs stemi strategy-it study)".Please see article for additional information.Specifically, this event captures case 6 from table 3 in the article.

• 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: 10817193
• MDR Text Key: 215528488
• Report Number: 2024168-2020-09364
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): Y
• Reporter Country Code: IT
• 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: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1012462-18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR