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

Catalog Number 1012581-19

Device Problems Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)

Patient Problems Low Blood Pressure/ Hypotension (1914); Thrombosis (2100)

Event Date 01/02/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned for analysis.It should be noted that the domestic instructions for use, (ifu), 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.In addition, it was reported that the graftmaster was deployed with a maximum pressure of 19 atm.The ifu specifies the rated burst pressure (rbp) is 16 atm and clearly states not to exceed the rbp.It is unknown if the ifu deviations contributed to the reported event.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 identified no similar incidents from this lot.The investigation determined a conclusive cause for the reported migration of device or device component cannot be determined; however, the subsequent treatment appears to be related to the circumstances of the procedure.The reported patient effects of hypotension and thrombosis as listed in the ifu are known patient effects that may be associated with use of a coronary stent in native coronary arteries.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that during a biopsy procedure on (b)(6) 2018, right renal arteriograms showed a large pseudoaneurysm arising from the posterior division just distal to the trifurcation of the right renal artery.A 3.50 x 19 mm graftmaster rx covered stent delivery system (sds) was selected to treat the pseudoaneurysm.The graftmaster rx sds was advanced to the pseudoaneurysm and the balloon was initially inflated to 15 atmospheres (atm).Digital subtraction imaging showed that there was still persistent bleeding.The balloon was then inflated to 19 atm.Subsequent imaging showed that there were clots developing within the distal right renal branches.The balloon was deflated and the graftmaster rx sds was removed from the anatomy.During removal of the graftmaster rx sds and the unspecified guide wire from the anatomy, the covered stent migrated proximally due to the tip of the guide wire being trapped beneath the covered stent.Subsequent right renal arteriogram showed no active bleeding, further propagation of clots and non-visualization of major part of the right kidney.The entire renal artery became thrombosed.The decision was made at that time to stop the procedure and not attempt thrombectomy.The patient remained hypotensive requiring pressors on a ventilator and is dialysis dependent.The patient was placed on inpatient hospice and provided comfort care.No additional information 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: 7226682
• MDR Text Key: 98516617
• Report Number: 2024168-2018-00668
• Device Sequence Number: 1
• Product Code: MAF
• UDI-Device Identifier: 08717648176401
• UDI-Public: 08717648176401
• 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: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 1012581-19
• Device Lot Number: 6121441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 74 YR