MAUDE Adverse Event Report: AV-TEMECULA-CT GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

Catalog Number 1012818-16

Device Problems Positioning Failure (1158); Inflation Problem (1310); Difficult To Position (1467); Difficult to Remove (1528); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2017

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 is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the patient presented with an aneurysm in the mid anterior cerebral artery; there was no active bleeding or extravasation of dye.A 3.5x16mm rx graftmaster covered stent system was advanced but was initially unable to cross the aneurysm due to interaction with an unspecified 0.014 guide wire and a non-abbott 7fr guiding catheter.The graftmaster ultimately crossed with slight force was applied.An attempt was made to inflate the graftmaster to between 10 and 15 atmospheres, but it failed to inflate and the stent did not expand at all.The graftmaster stent system was withdrawn with slight difficulty, possibly due to the device interaction.Upon withdrawal from the anatomy, another attempt was made to inflate the graftmaster when a hole was noted in the middle of the graftmaster balloon with dye leaking from the hole.Another unspecified same size stent graft was used to successfully treat the aneurysm.There were no adverse patient sequelae and no occurrence of a clinically significant delay.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: a visual, functional and dimensional inspection was performed on the returned device.The reported inflation issue, shaft leak and failure to deploy were confirmed.The reported difficult to remove (guide catheter) and difficult to remove (guide wire) could not be tested due to the condition of the returned device.In addition, the reported difficult to position (guide catheter) and difficult to position (guide wire) could not be confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents.It should be noted that the graftmaster coronary stent graft system instructions for use (ifu) states: the graftmaster rx is a balloon-expandable pre-mounted coronary stent graft for intraluminal chronic placement in coronary arteries or aorto-coronary bypass grafts for the treatment of coronary artery aneurysm, coronary bypass-vein graft aneurysm, acute coronary artery perforation and acute coronary artery rupture.Furthermore, it was reported that resistance was felt during advancement of the stent delivery system (sds) and force was applied.The graftmaster coronary stent graft system instructions for use (ifu) states: caution: if resistance is encountered, do not force passage.Resistance may indicate damage to the device or movement of the stent graft on the balloon.The investigation determined the reported difficulties appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

Event Description

Subsequent to the initial filed medwatch report, the abbott vascular returned goods lab received the device with a pinhole in the mid shaft area and the distal shaft area, but not in the balloon, as initially reported.Additional information received confirmed that the correct complaint device was returned and the physician confirmed that reported pinhole is located on the mid shaft area, and not the balloon itself.No additional information was provided.

• Brand Name: GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
• Type of Device: CORONARY STENT GRAFT
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; 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: 6605229
• MDR Text Key: 76593258
• Report Number: 2024168-2017-04676
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: H000001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/14/2017

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: 06/30/2017
• Device Catalogue Number: 1012818-16
• Device Lot Number: 5071441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2017
• Initial Date FDA Received: 06/01/2017
• Supplement Dates Manufacturer Received: 07/12/2017
• Supplement Dates FDA Received: 07/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• 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: 70 YR
• Patient Weight: 76