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

Catalog Number 1012463-18

Device Problems Kinked (1339); Torn Material (3024)

Patient Problem No Patient Involvement (2645)

Event Date 12/23/2013

Event Type  malfunction  

Event Description

It was reported that during preparation of the 3.0 x 18 mm device, a kinked tip was observed after removing the protective sheath segments and the stylet from the delivery system.The device was not used.There was no contact with the patient.A new same size device was used to continue the procedure.There was no clinically significant delay in procedure.There was a good final patient outcome.No additional information was provided.Returned device analysis revealed the tip was torn and nearly detached.

Manufacturer Narrative

(b)(4).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.The product code listed and the pma # are based on the predicate device (xience v stent system) that is determined to be same and similar to the delivery system of this device.Evaluation summary: the device was returned for analysis.The kinked tip was unable to be confirmed; however the tip was torn which is likely the damage reported by the account.Based on a visual inspection 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 the reported event.A query of the complaint handling database revealed no other incidents for tip damage (kinks/tears) reported from this lot.Based on the reviewed information, no product deficiency was identified.

• 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: 3691347
• MDR Text Key: 15812544
• Report Number: 2024168-2014-01681
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2014
• Device Catalogue Number: 1012463-18
• Device Lot Number: 3062561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• 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