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

Catalog Number 1012462-28

Device Problems Peeled/Delaminated (1454); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2014

Event Type  malfunction  

Event Description

The procedure was to treat a moderately tortuous, mildly calcified, de novo lesion in the right coronary artery (rca).The 2.5x28 mm device did not cross the lesion even after adequate pre-dilatation with a semi complaint balloon (residual stenosis was close to 50%).Proximal calcification was suspected and the device was removed.Without further dilatation, the procedure was completed using a xience xpedition of the same size.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.The returned device evaluation found that there was balloon material shredding at the proximal balloon shaft.

Manufacturer Narrative

(b)(4).Residual stenosis was close to 50%.The device was received.Investigation is not yet complete.A follow up report will be submitted with all 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).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.However, there was balloon material shredding at the proximal balloon shaft.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.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.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: 4358917
• MDR Text Key: 5174391
• Report Number: 2024168-2014-08489
• 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,Followup
• Report Date: 10/07/2014

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: 03/31/2015
• Device Catalogue Number: 1012462-28
• Device Lot Number: 4040161
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/02/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/02/2015
• Initial Date FDA Received: 12/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/14/2015
• 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