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

Catalog Number 1012581-19

Device Problems Positioning Failure (1158); Inflation Problem (1310); Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Continued: on (b)(6) 2016, the patient presented with acute epistaxis (hemorrhage from nostril) and a lica aneurysm.A small leak was discovered at the 4.0x26mm rx graftmaster.An attempt was made to treat the leak and to better appose the graftmaster to the vessel wall via inflation with an unspecified 5.0x12 non-compliant balloon, but the leak persisted.Another attempt to treat the leak was made using a 3.5x19mm rx graftmaster, however, upon attempted balloon inflation, the balloon did not inflate and the stent failed to deploy; blood in the stent delivery device hub was identified.Thus, the 3.5x19 rx graftmaster was withdrawn.Another attempt was made to treat the leak using a 2.8x16 rx graftmaster, however, this device failed to cross due to difficult anatomy and insufficient support from the guide catheter; the graftmaster was withdrawn without resistance when a crinkled (bunched) shaft was noted approximately 10-15 cm proximal to the stent.Thus, no further advancement attempts were made.A 2.8x19 rx graftmaster was then advanced over a 0.014 prowater guide wire, but this graftmaster was difficult to advance around the carotid siphon; thus, a non-abbott 6fr guideliner was advanced and assisted advancement of this graftmaster; it was deployed with a max pressure of 16 atm and reportedly sealed the leak, distally overlapping the 1st implanted stent.Vasospasm occurred at the location of the 1st implanted stent.Additional angioplasty was then performed on implanted stents, relieving vasospasm in the 1st implanted stent.Angiogram showed persistent endoleak, but the amount of leak appeared to have decreased.Additional angioplasty of both implanted stents improved stent wall apposition.Angiography demonstrated no further residual leak; the endoleak was confirmed to be completely sealed.Reportedly, use of the graftmasters did not cause or contribute to complications, adverse events, or a clinically significant delay.The extended hospital stay is also reportedly unrelated to use of the graftmasters.No additional information was provided.Concomitant medical products: guide cath: neuron 70 guide catheter; roadmaster 71 guide catheter; neuron max 88 stent: 4.0x26mm rx graftmaster.(b)(4).It is indicated that the device is not returning for evaluation; therefore a failure analysis of the complaint device could not be completed.It has been determined that a conclusive cause for the reported difficulties cannot be determined and the subsequent treatment appears to be related to circumstances of the procedure.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.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.It should be noted that the graftmaster rapid exchange (rx) coronary stent graft system, domestic instructions for use states: the graftmaster rx is indicated for use in the treatment of free perforations, defined as free contrast extravasation into the pericardium, in native coronary vessels or saphenous vein bypass grafts greater than or equal to 2.75 mm in diameter.The additional 3 graftmasters referenced and the 4.0x26 rx graftmaster referenced in are being filed under separate manufacturing report numbers.

Event Description

It was reported that on (b)(6) 2016, the patient presented with a drill laceration / perforation in the left internal carotid artery (lica) that occurred during removal of a pituitary tumor that same day.An attempt was made to advance a 4.0x26mm rx graftmaster covered stent over a non-abbott 0.014 guide wire, but the graftmaster was unable to be advanced to the site due to the softness of the non-abbott wire; thus this wire was exchanged for a conventional cardiology wire and the graftmaster reached the target site.The balloon was partially inflated to partially expand the stent to counteract retrograde movement of the stent system around the curved vessel; this gave the stent traction and it was re-centered at the target deployment site.Once it was ascertained that device was in satisfactory but not ideal location, it was deployed with a max pressure of 10 atmospheres (atm).As the stent was 26mm long and the estimated lesion size was 5mm, there was about 10mm of leeway for positioning; the stent was implanted approximately 5mm from the ideal positioning with only 5mm of safety or normal vessel coverage.Selection of this longer graftmaster stent resulted in significant straightening of the curved vessel.The graftmaster sealed the perforation.A small proximal dissection occurred when inflating the graftmaster balloon to deploy the stent, but the dissection was not treated at that time.

• 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: 5485856
• MDR Text Key: 39871072
• Report Number: 2024168-2016-01395
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H000001
• 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: 03/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: 1012581-19
• Device Lot Number: 5071441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2016
• Initial Date FDA Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 91