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

Catalog Number 1012463-18

Device Problems Inflation Problem (1310); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2014

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a concentric lesion located in the mid left anterior descending (lad) artery.Pre-dilatation was performed with an unspecified balloon 2.5x15 mm at normal pressure with residual stenosis less than 40%.An implant 3.0x18 was advanced and crossed through a non-abbott stent 4.0x9 mm located in the trunk; however, when the implant was being deployed, the balloon never inflated.The implant was retracted and the balloon was noted to have a hole proximal.Another implant, 3.5x18 mm, was advanced in the vessel and deployed without any problem.The patient was returned to his room.No adverse patient effects or clinically significant delay in procedure.There was no resistance or difficulty noted while removing the protective sheaths from the device prior to use.No additional information was provided.

Manufacturer Narrative

(b)(4).Concomitant products: guide wire: asahi soft; guide catheter: launcher; stent: integrity 4.0x9.Though the device is not approved for sale in the us, it uses a delivery system which is similar to a device sold in the us.The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for evaluation.The inflation issue was confirmed.The balloon was separated at the proximal seal.Based on visual and functional analysis of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to this complaint.A query/review of the complaint history of the reported lot did not indicate a manufacturing issue.Based on the information reviewed, there is no indication of a product deficiency.

• 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: 3956225
• MDR Text Key: 4621822
• Report Number: 2024168-2014-04779
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/20/2014
• Device Catalogue Number: 1012463-18
• Device Lot Number: 3102162
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/16/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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
• Patient Age: 50 YR
• Patient Weight: 65