MAUDE Adverse Event Report: AV-TEMECULA-CT ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1012462-18

Device Problems Inflation Problem (1310); Leak/Splash (1354); Torn Material (3024)

Patient Problems Air Embolism (1697); Pain (1994)

Event Date 01/16/2014

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a lesion located in the proximal to mid left anterior descending (lad) artery with no calcification or tortuosity.The lesion was pre-dilated as per the instructions for use with a non-abbott semi-compliant balloon (2.5x15).After pre-dilatation a good angiographic result was noted with residual stenosis less than 40%.The 2.5x18 device was placed at the target lesion.At the moment of inflating the device (increments of 2 atmospheres (atm) every 5 seconds) the balloon did not inflate.Under fluoroscopy it was noticed that contrast was exiting from the delivery system.It was also noticed that some air bubbles were exiting from the delivery system.The patient experienced some non-anginal pain.The device was removed from the patient anatomy and the procedure was concluded with success by using a xience xpedition (2.25x23) at 11 atm.The pain disappeared.The patient is reported to be fine.Out of the patient the physician inflated the device and noticed a hole in the proximal shaft before the balloon which was not noted prior to using the device in the patient anatomy.It was confirmed that no resistance was encountered during advancing.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Though the device is not approved for sale in the u.S., it uses a delivery system which is similar to a device sold in the u.S.

• Brand Name: ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 3613899
• MDR Text Key: 4066921
• Report Number: 2024168-2014-00732
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1012462-18
• Device Lot Number: 3050761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2014
• Was Device Evaluated by Manufacturer?: No
• 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