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 Cardiac Arrest (1762)

Event Date 03/01/2016

Event Type  Injury  

Manufacturer Narrative

Event, implant, treatment, and implant dates: dates estimated.The udi is unknown because the part number and lot number were not provided.The device was not returned for analysis.A review of the lot history record and complaint history of the reported device could not be conducted because the lot and part number were not provided.A conclusive cause for the difficulties listed can not be determined based on the limited information available.The patient effects listed are consistent with the product risk profile and are therefore expected.The absorb device is not currently sold in the u.S.; however, it is similar to a device sold in the u.S.Article "pre-emptive oct-guided angioplasty of vulnerable intermediate coronary lesions: results from the prematurely halted pectus-trial".

Event Description

It was reported in an article that during implantation of an absorb bioresorbable vascular scaffold (bvs), cardiac arrest occurred due to pulseless electrical activity.Chest compressions were performed for 1 minute and atropine was given.Spontaneous circulation then occurred.There were no device issues noted.Episode was attributed to a vagal reaction.Specific patient and procedural information is not available.More information can be accessed in the attached article "pre-emptive oct-guided angioplasty of vulnerable intermediate coronary lesions: results from the prematurely halted pectus-trial".

• 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: 11166908
• MDR Text Key: 226781298
• Report Number: 2024168-2021-00418
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): Y
• Reporter Country Code: NL
• 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: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention