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 04/16/2014

Event Type  malfunction  

Event Description

It was reported that the patient was diagnosed with a de novo lesion in the mid right coronary artery (rca) with heavy tortuosity, mild calcification, and 95% stenosis.Pre-dilatation was done with a 2.75mm balloon at 12 atmospheres (atm) with the residual stenosis less than 40%.A 3.0x28 mm implant was advanced; however, did not cross the lesion due to the anatomy.A 3.0x28 mm xience v stent was able to cross the lesion and was deployed successfully.There was a good final patient outcome.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 noted balloon material shredding on the distal and proximal balloon taper.

Manufacturer Narrative

(b)(4).Though the device is not approved for sale in the us, it uses a delivery system which is similar to a device sold in the us.Evaluation summary: the device was returned for evaluation and balloon material shredding on the distal and proximal balloon taper was noted.The failure to advance could not be replicated in a testing environment as it was based on operational circumstances.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: 3841790
• MDR Text Key: 4616182
• Report Number: 2024168-2014-03509
• 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: 04/16/2014

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: 05/07/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2014
• Initial Date FDA Received: 05/30/2014
• 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
• Treatment: GUIDE WIRE: BMW, GUIDE CATHETER: EBU