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 12/30/2013

Event Type  malfunction  

Event Description

It was reported that the lesion was prepared first by the percutaneous transluminal coronary angioplasty balloon catheter which was fully inflated.Then the 2.5x18 mm device was introduced to cross the lesion and they tried to increase the pressure to 2 atmospheres several times but it failed.The device was withdrawn outside the patient and was inflated and they found big perforation at the proximal end of the device.There was no reported clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Event Description

Subsequent to the initial medwatch report, additional information was received stating that after pre-dilatation, the residual stenosis was 50%.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional 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.

Manufacturer Narrative

(b)(4) - failure to follow steps.Evaluation summary: the device was returned for evaluation.The torn material (perforation) was confirmed.The reported inflation issue could not be replicated as the returned device was not returned in a condition in which the test could be performed.Based on visual 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.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.It should be noted that the instructions for use (ifu) warns: it is not recommended to treat patients having a lesion that prevents complete inflation of an angioplasty balloon, or a lesion with greater than 40% residual stenosis after pre-dilatation by visual estimation.In this case, it is unknown if the ifu deviation directly caused or contributed to the reported difficulties.

• 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: 3591893
• MDR Text Key: 4036443
• Report Number: 2024168-2014-00418
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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,Followup
• Report Date: 01/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2014
• Device Catalogue Number: 1012462-18
• Device Lot Number: 302186N
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/20/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2013
• 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
• Treatment: GUIDE CATH: XB3.5 6C 6F, GUIDE WIRE: ASAHI SION
• Patient Age: 67 YR