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

Catalog Number 1012464-28

Device Problems Kinked (1339); Failure to Advance (2524); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/22/2014

Event Type  malfunction  

Event Description

During an interventional procedure the device could not cross the target lesion, even though it had been pre-dilatated and the residual stenosis was less than 40%.A proximal kink in the shaft was noticed.The physician replaced the device with a new one and everything went fine.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.The returned device revealed a tear/hole in the proximal taper of the balloon.

Manufacturer Narrative

(b)(4).Date of event is estimated.Evaluation summary: the device was returned for evaluation.The reported kinked proximal shaft was confirmed.The failure to advance could not be replicated in a testing environment as it was based on operational circumstances.A tear/hole in the balloon was noted.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 of the electronic complaint handling database revealed no other incidents for failure to advance or kinks reported from this lot.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: 4334879
• MDR Text Key: 21719612
• Report Number: 2024168-2014-08208
• 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: 09/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2015
• Device Catalogue Number: 1012464-28
• Device Lot Number: 4040361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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