MAUDE Adverse Event Report: AV-TEMECULA-CT ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE DRUG ELUTING SCAFFOLD

Catalog Number 1235300-12

Device Problems Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was not returned for evaluation.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history did not indicate a lot specific quality issue.It should be noted that the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use states: a non sterile temperature monitor for the shipping and storage of the absorb gt1 bvs system has been included with the product.Before use of this product, check the temperature indicator located through the window in the back of the product box.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.The other absorb gt1 3.5 x 15 referenced is filed under a separate medwatch report number.

Event Description

It was reported that the procedure was to treat the left anterior descending artery.The temperature monitors (tag alerts) on two absorb gt1 scaffolds, a 3.0 x 12 mm and a 3.5 x 18 mm, triggered due to improper storage at the account; however, the devices were used anyway.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.

• Brand Name: ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Type of Device: BIORESORBABLE DRUG ELUTING SCAFFOLD
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6513896
• MDR Text Key: 73732699
• Report Number: 2024168-2017-03511
• Device Sequence Number: 1
• Product Code: PNY
• UDI-Device Identifier: 08717648213021
• UDI-Public: (01)08717648213021(17)170515(10)6051661
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2017
• Device Catalogue Number: 1235300-12
• Device Lot Number: 6051661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2016
• 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: 51 YR
• Patient Weight: 75