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

Catalog Number 1012581-16

Device Problems Difficult or Delayed Positioning (1157); Positioning Failure (1158); Physical Resistance (2578); Device Dislodged or Dislocated (2923)

Patient Problems Angina (1710); Ischemia (1942); Occlusion (1984)

Event Date 10/11/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).Case description continued: an angiography revealed an occlusion in the cx at the distal part of the graftmaster, but the occlusion cause was unable to be determined.An unspecified 2.5x12 balloon was then advanced to the graftmaster and inflated, resulting in timi 3 flow.A 3.0x18 non-abbott bare metal stent (bms) was then deployed distal to the graftmaster, overlapping the distal end of the graftmaster, followed by post-dilatation of the overlap area.A 3.0x22 non-abbott bms was then advanced into the lad and positioned so that the proximal end of this bms extended from the lad into the left main and aligned next to the proximal end of the graftmaster that extended from the cx into the left main.Angiography showed restoration of timi 3 flow in both the lad and cx, however, a waist was noted in the proximal cx (where the graftmaster is implanted).Thus, post-dilatation was performed using an unspecified 3.5x8 nc balloon inflated to 20 atmospheres (atm).The procedure was concluded with 0% residual stenosis, resolved chest pain, and stable hemodynamics.The inability to cross caused a delay, however, the delay reportedly did not cause harm to the patient.The patient was observed overnight in the intensive care unit, but there were no adverse sequelae and the patient was discharged the next day.No additional information was provided.Atrial flutter ((b)(6) 2008), angina effort ((b)(6) 2011), and anemia ((b)(6) 2014).The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The hi-torque whisper es guide wire referenced is being filed under a separate manufacturing report number.

Event Description

It was reported that the procedure was to treat a lesion located in a 95% stenosed, moderately calcified, heavily tortuous ostial circumflex coronary (cx) artery.A free perforation with extravasation was noted after treating the lesion with an unspecified whisper es guide wire and an unspecified laser atherectomy device.Reportedly, both devices caused the perforation.A guideliner delivery catheter was required to facilitate delivery of the whisper es wire, due to the heavy vessel tortuosity, but no other device issues were noted with the whisper.A 3.5x16 rx graftmaster covered stent was advanced via radial access toward the perforation, but the stent dislodged when barely crossing the perforation, due to the vessel tortuosity.Attempts were made to retrieve the stent by advancing a 1.2mm and a 2.0mm balloon past then stent, inflating each balloon, then attempting to pull the stent back with the inflated balloon, but each attempt failed.The graftmaster stent was deployed using nc balloons (3.0x6 and 3.0x8), extending from the left main to the ostial circumflex.The proximal half was deployed in healthy tissue in the left main with the distal half still completely covering and sealing the perforation in the ostial circumflex.The patient experienced acute chest pain.Sluggish flow was noted in the left anterior descending (lad) coronary artery, which was reportedly due to the deployed graftmaster blocking flow from the left main to the lad and due to a pre-existing stenosed lesion.***case description continued in h10.***.

Manufacturer Narrative

(b)(4).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 identified no similar incidents from this lot.The reported patient effects of occlusion and ischemia, as listed in the graftmaster rx coronary stent graft system, instructions for use (ifu), are known patient effects that may be associated with use of a coronary stent in native coronary arteries.The investigation determined that the reported difficulties and reported treatment appears to be related to circumstances of the procedure; however, a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.Based on the information reviewed, 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: 6077208
• MDR Text Key: 59115315
• Report Number: 2024168-2016-07557
• 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: 11/09/2016

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: 01/31/2018
• Device Catalogue Number: 1012581-16
• Device Lot Number: 6021741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2016
• Initial Date FDA Received: 11/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/09/2016
• 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
• Treatment: GUIDE WIRE: WHISPER ES
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 122