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

Catalog Number 1012582-16

Device Problems Positioning Failure (1158); Difficult to Remove (1528); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017); Physical Resistance (2578); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/17/2017

Event Type  Injury  

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 additional relevant information.The additional graftmaster devices (4.5x16mm (x2), 4.0x16mm) referenced are being filed under separate medwatch report numbers.User facility medwatch report# (b)(4).(it was confirmed by the physician that the size listed on this report should have been a 4.0 x 16 mm graftmaster).

Event Description

It was reported that the procedure on (b)(6) 2017 was to treat a fistula in the distal carotid artery with heavy tortuosity and no calcification.A 4.5 x 16 mm graftmaster stent delivery system (sds) was advanced to the lesion but would not cross and the shaft peeling was observed due to the resistance with the anatomy.A 4.0 x 16 mm graftmaster sds was advanced to the lesion with resistance and the balloon ruptured between 7 and 8 atmospheres which resulted in only the distal and proximal edges of the stent expanding.Resistance was felt during removal of the sds due to the partially expanded it could not be pulled back into the guide catheter.When the sds was three quarters of the way out of the carotid artery, the stent implant dislodged from the balloon and was free floating inside the vessel.The stent was snared and removed from the patient.The patient was stable and the lesion was left untreated.The follow-up procedure was performed on (b)(6) 2017.A 4.5 x 16 mm graftmaster sds was advanced to the lesion; however, it would not cross it and the proximal shaft separated outside the patient.The device was removed and a new 4.5 x 16 mm graftmaster stent was successfully deployed.A small endoleak was observed and a 4.0 x 16 mm graftmaster was advanced to the lesion to treat the leak; however, the balloon failed to inflate.Two additional graftmaster stents (4.0 x 19 mm, 4.5 x 26 mm), were deployed overlapping, but the endoleak persisted.A non-abbott balloon was used to treat the leak.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was initially reported as returning for analysis, but has now been reported as not returning because it was discarded at the account.The device was not returned for analysis.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 did not indicate a lot specific quality issue.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 investigation determined the reported physical resistance, material rupture, failure to deploy, difficult to remove and stent dislodgement appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

• 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: 6481888
• MDR Text Key: 72432565
• Report Number: 2024168-2017-03028
• 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,Followup
• Report Date: 04/28/2017

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: 01/31/2018
• Device Catalogue Number: 1012582-16
• Device Lot Number: 6021641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2017
• Initial Date FDA Received: 04/11/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2016
• 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: 72 YR
• Patient Weight: 91