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

Catalog Number 1012463-18

Device Problems Break (1069); Difficult to Remove (1528); Folded (2630)

Patient Problem No Patient Involvement (2645)

Event Date 08/26/2014

Event Type  malfunction  

Event Description

It was reported that the drug eluting coronary device was stuck to the protective sheath.Upon device return, the device was set aside for return, and not used.There was no patient involvement.There was no additional information provided.Returned device analysis found that the balloon had separated from the outer member at distal end of proximal balloon.The inner member was still intact.The proximal balloon shaft and the outer member were jagged at the separation and the balloon was bunched at the distal balloon shoulder and the distal balloon taper.

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 device was returned for evaluation.The reported difficulty removing the protective sheaths could not be replicated in a testing environment due to the condition of the returned device.Analysis of the returned drug eluting coronary device noted no blood or contrast visible.The undamaged scaffold was stationary on the tightly folded balloon where it was initially crimped on.The balloon was bunched at the distal balloon shoulder and the distal balloon taper.The balloon was separated from the outer member at the distal end of the proximal balloon seal but the inner member was still intact.The device was not separated into two pieces.Based on visual and dimensional 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 the reported event.The results of the query of similar incidents in the complaint handling database for this 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: 4182077
• MDR Text Key: 5101818
• Report Number: 2024168-2014-06776
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2015
• Device Catalogue Number: 1012463-18
• Device Lot Number: 4030761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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: 72 YR
• Patient Weight: 88