MAUDE Adverse Event Report: ABBOTT VASCULAR ABSORB; BIORESORBABLE SCAFFOLD

Catalog Number 1012463-28

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

Patient Problem Thrombosis (2100)

Event Date 09/21/2013

Event Type  Injury  

Manufacturer Narrative

Estimated dates.Exemption number (b)(4) 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 scaffold remains in patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the u.S.Na.

Event Description

It was reported that an acute stent thrombosis was noted after an unk absorb biodegradable vascular scaffold stent was implanted.No additional information was provided.

Manufacturer Narrative

Exemption number (b)(4) 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.There was no reported device malfunction and the product was not returned as the scaffold remains in the anatomy.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of thrombosis, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use, is a known adverse event associated with 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.

Event Description

The event detailed in the initially filed report was received without a date of occurrence and was filed with an estimated date of (b)(6) 2019.Subsequent to the initially filed report, the following information was received: the event occurred during the devices ide approval period and the full event details were captured per clinical ide procedures at that time.

• Brand Name: ABSORB
• Type of Device: BIORESORBABLE SCAFFOLD
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8843759
• MDR Text Key: 152755639
• Report Number: 2024168-2019-10464
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2013
• Device Catalogue Number: 1012463-28
• Device Lot Number: 305206A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR