MAUDE Adverse Event Report: AV-TEMECULA-CT MULTI-LINK RX VISION CORONARY STENT SYSTEM

Catalog Number 1007849-12

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2013

Event Type  malfunction  

Event Description

It was reported that the hub on a 3.5x12mm vision stent delivery system cracked during an unspecified procedure, requiring manipulation of the device to deploy the stent.There was no report of adverse patient sequela and no report of a clinically significant delay.There was no additional information provided.

Event Description

It was reported that during a right coronary artery stenting procedure, a 3.5x12mm vision stent moved proximal to the balloon and was unable to be deployed.The device was removed from the anatomy without reported issue.There was no adverse patient sequela and no clinically significant delay.There was no additional information provided.

Manufacturer Narrative

(b)(4).Date of event has been estimated.It is currently unknown if the device is returning.A sterile device representing this incident, referenced under case two, is returning.It has not yet been received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

(b)(4).The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

(b)(4).It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.A review of the lot history record revealed no non-conformances that would have contributed to this complaint.A query of the electronic complaint handling database revealed no other incidents for unstable stent reported from this lot.Based on the information reviewed, there is no evidence to indicate the presence of a product deficiency.

• Brand Name: MULTI-LINK RX VISION CORONARY STENT SYSTEM
• Type of Device: CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; 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: 3551218
• MDR Text Key: 4046721
• Report Number: 2024168-2014-00066
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P020047
• 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,Followup,Followup
• Report Date: 12/10/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2015
• Device Catalogue Number: 1007849-12
• Device Lot Number: 2022441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2012
• 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 Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 74