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

Catalog Number 1012463-28

Device Problems Peeled/Delaminated (1454); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2014

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a lesion in the left circumflex (lcx) artery, with heavy tortuosity and mild calcification.Pre-dilatation was performed with a 2.5 x 12mm non-compliant (nc) balloon at 16 and 18 atmospheres, reducing the stenosis to less than 40%.The 3.0 x 28 mm device was advanced, but could not cross due to the anatomy.A xience xpedition was used to successfully complete the procedure.There was no reported clinically significant delay due to the failure to cross.There was no adverse patient effect.No additional information was provided.Returned device analysis on (b)(4) 2014 observed material peeling on the balloon.

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.Evaluation summary: the device was returned for evaluation.The failure to advance could not be replicated in a testing environment as it was based on operational circumstances.Balloon shredding/peeling was observed, which was likely caused by the interaction with the tortuosity and calcification.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 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: 3873257
• MDR Text Key: 4570352
• Report Number: 2024168-2014-03848
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 04/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2014
• Device Catalogue Number: 1012463-28
• Device Lot Number: 3102861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2014
• Initial Date FDA Received: 06/13/2014
• 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: 49 YR
• Patient Weight: 60