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

Catalog Number UNK ABSORB

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

Patient Problem Death (1802)

Event Date 11/01/2016

Event Type  Death  

Manufacturer Narrative

Exemption number (b)(4).The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the u.S.Product performance engineering reviewed the incident information; however, there was no reported device malfunction and the product was not returned.A review of the lot history record and complaint history could not be conducted because the part and lot number were not provided.The reported patient effects of death, is listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use (ifu) as a known adverse event associated with the use of a coronary scaffold in native coronary arteries.Based on the case information, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.(b)(4).

Event Description

It was reported through a research article that absorb bioresorbable vascular scaffolds may be related to death.Specific patient information is documented as unknown.Details are listed in the article titled: two-year clinical outcomes of the ¿italian diffuse/multivessel disease absorb prospective registry¿ (it-disappears).

Manufacturer Narrative

Date of death, event and implant: are estimated dates.In the absence of reported part number, unique device identifier (udi) cannot be calculated.Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the u.S.Product performance engineering reviewed the incident information; however, there was no reported device malfunction and the product was not returned.A review of the lot history record and complaint history could not be conducted because the part and lot number were not provided.The reported patient effects of death, is listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use (ifu) as a known adverse event associated wit the use of a coronary scaffold in native coronary arteries.Based on the case information and related record review, 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 design, manufacture or labeling of the device.(b)(4).

Event Description

It was reported through a research article that absorb bioresorbable vascular scaffolds may be related to death.Specific patient information is documented as unknown.Details are listed in the attached article titled: two-year clinical outcomes of the ¿(b)(4) diffuse/multivessel disease absorb prospective registry¿ (it-disappears).

Manufacturer Narrative

This report is resubmitted to ensure the enclosed attachment can be easily opened by the fda.Attachment: literature attachment "two- year clinical outcomes of the italian diffuse/multivessel disease absorb prospective registry (it-dissapears).

• Brand Name: ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Type of Device: BIORESORBABLE SCAFFOLD
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8828117
• MDR Text Key: 152246742
• Report Number: 2024168-2019-10375
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): Y
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup,Followup
• Report Date: 07/21/2020

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: UNK ABSORB
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/03/2019
• Initial Date FDA Received: 07/25/2019
• Supplement Dates Manufacturer Received: 07/25/2019; 07/20/2020
• Supplement Dates FDA Received: 08/02/2019; 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 60 YR