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); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2014

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a critically narrowed (almost total occlusion) circumflex artery.Pre-dilatation was performed with a trek balloon.The 2.5 x 18 mm device was advanced to the lesion without resistance; however, when pressurized the balloon would not inflate.Once the device was removed, a hole in the catheter was observed 2 cm proximal to the implant.A new same size device was used to successfully treat the lesion.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the complaint device was returned for analysis.The reported inflation issue and hole in the device (shaft separation) were confirmed.Based on the visual and functional analysis of the 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 the reported event.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.

Manufacturer Narrative

(b)(4).Concomitant products: guide wire: balance middleweight; guide cath: medtronic launcher; sheath: balton.The device was received.Investigation is not yet complete.A follow up report will be submitted with all 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: 3887373
• MDR Text Key: 4673424
• Report Number: 2024168-2014-03992
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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,Followup
• Report Date: 05/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2014
• Device Catalogue Number: 1012462-18
• Device Lot Number: 3111461
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/19/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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: 46 YR
• Patient Weight: 75