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

Catalog Number 1012581-16

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

Patient Problem Death (1802)

Event Date 02/18/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: guide wire: 0.35 bentson wire,.035 stiff angled,.014 nitrex,.014 choice pt, mailman super support.Guide cath: 5f vcf.Sheath: 5f terumo, 5f destination, 6f destination, 6f ansel.Stent: 3.5x12mm rebel bare metal stent, 3.5x26mm graftmaster.Other: 2mmx1cm ruby coil soft (2x), 2mmx4cm ruby coil soft (2x), 3mmx5cm ruby coil soft.(b)(4).The device was not returned for analysis.The reported patient effect of death is listed in the graftmaster rapid exchange (rx) coronary stent graft system, domestic instructions for use (ifu) as a known patient effect of coronary stenting procedures.It was reported that the graftmaster was used in the common hepatic artery.It should be noted that the graftmaster rx coronary stent graft system, domestic 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.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.The investigation was unable to determine a conclusive cause for the reported failure to seal the perforation; however, the reported migration of device or device component (stent) and difficult to remove appear to be related to the operational context of the procedure.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 the patient presented in cath lab in hypovolemic shock due to gastrointestinal bleeding and bleeding right proximal hepatic artery.An angiogram was performed and coil embolization and implantation of a bare metal stent was performed but bleeding continued.A 3.5x16mm graftmaster covered stent was implanted in the common hepatic artery.During balloon removal, the stent stuck to the balloon and the stent moved from its original position into the more proximal common hepatic artery.After successfully removing the balloon from the stent, a second 3.5x26mm graftmaster covered stent was implanted overlapping the first graftmaster and covering the origin of the bleeding vessel.One more coil was placed in the bleeding vessel.Bleeding slowed significantly but was still present.This was felt to be secondary to flow through the material of the graftmaster stent.The procedure ended with no obvious variceal bleeding.The patient was referred to surgery but was determined to not be a surgical candidate.The patient continued in shock, disseminated intravascular coagulation (dic), ongoing bleeding, and acidosis.The patient made do not resuscitate and expired from dic, shock, uncontrolled bleeding and perforated duodenal ulcer.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: 7336723
• MDR Text Key: 102304584
• Report Number: 2024168-2018-01801
• Device Sequence Number: 1
• Product Code: MAF
• UDI-Device Identifier: 08717648176395
• UDI-Public: 08717648176395
• 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: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 1012581-16
• Device Lot Number: 6111141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2016
• 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): Death
• Patient Age: 70 YR
• Patient Weight: 73