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

Catalog Number 1012580-26

Device Problems Device Expiration Issue (1216); Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

Patient Problems Anemia (1706); Arrhythmia (1721); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Swelling (2091); Ventricular Fibrillation (2130); Respiratory Failure (2484); Test Result (2695)

Event Date 03/09/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) during the surgery, an extra stiff wire was placed at the cath site to put patient on bypass machine.The three graftmaster stents were discovered to be outside of the lad, protruding into the pericardium.The three graftmaster stents were removed from the pericardium.Ligation of the lad was performed and the lad was bypassed via saphenous vein graft.Patient had 2 plus edema and gained 24 pounds ((b)(6)) between (b)(6) 2016.The patient was extubated on (b)(6) 2016.As of(b)(6) 2016, weight is steadily declining with continued diuresis.Patient experienced acute anemia and thrombocytopenia due to blood loss, and received platelets on (b)(6) 2016.While there was a decline in hemoglobin value of 9.8 on (b)(6) 2016 to 9.2 on (b)(6) 2016, the patient hemoglobin was recovering and had a hemoglobin value of 9.6 at discharge.The patient was discharged with no adverse sequelae as of (b)(6) 2016.Reportedly, the two expired graftmaster stents had expired in february 2016, but the site did not have other graftmaster devices of those sizes on-hand; these expired stents were intentionally deployed due to the emergent need for use for this patient.No additional information was provided.(b)(4) during processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: guide wire: grand slam.Stent: a 2.25x32 promus (boston scientific); a 2.75x38 promus (boston scientific); a 2.8x19 rx graftmaster (x2).Guide cath: guideliner.(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 relevant information.The guidewire and graftmaster rx device(s) referenced are being filed under a separate manufacturing report number.

Event Description

It was reported that on (b)(6) 2016, the patient underwent a percutaneous coronary intervention to treat a chronic total occlusion in the mid to distal left anterior descending (lad) coronary artery via deployment of a 2.25x32 non-abbott stent in the most distal segment, then via deployment of a 2.75x38 non-abbott stent in the mid lad.Angiography showed a perforation with extravasation in the mid lad.Reportedly, while no guide wire device issues were noted with any of the guide wires used, the last guide wire used in the procedure (a grand slam wire) is believed to have contributed to the perforation, as the occluded vessel did not allow the wire to follow the vessel path.Pericardiocentesis was performed.The patient went into cardiac arrest and cardiopulmonary resuscitation (cpr) was initiated.A 2.8x19 rx graftmaster, then an expired 2.8x19 rx graftmaster, followed by an expired 2.8x26 rx graftmaster covered stents were each implanted in the lad in an attempt to seal the perforation with each deployment; after placement of each stent, there was still no improvement to bleeding.Cpr was continued and the patient redeveloped escape rhythm and intermittent sinus rhythm (arrhythmia).The patient intubated and was emergently transferred to the operating room for open heart surgery.The patient was in ventricular fibrillation at the start of surgery and was cardioverted back to a normal ventricular rhythm.Left ventricular (lv) function was very poor with severe global hypokinesis.The patient was allowed to recover via bypass machine for over 90 minutes and epinephrine was administered, improving blood pressure and lv function.

Manufacturer Narrative

(b)(4).Evaluation summary: a visual inspection was performed on the returned stent, but the catheter was not returned for analysis.The investigation was unable to determine a conclusive cause for the reported failure to seal the perforation or stent migration.The reported patient effects of arrhythmia, hypotension and ventricular fibrillation 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.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however the reported treatments appear to be related to the circumstances of the procedure.Furthermore, it was reported that the graftmaster was used past the expiration date.A review of the graftmaster label attached to the lot history record for this lot was conducted indicating a manufacturing date of 31-march-2014 with an expiration date (use by date) of 29-february-2016.The product was used after expiration as it was reported the procedure occurred on (b)(6) 2016.The expiration date of the product is important for sterility, efficacy, and performance of the device.It should be noted that the graftmaster rapid exchange (rx), coronary stent graft system, domestic instructions for use, (ifu) states: note the product use by date specified on the package.Additionally, it is unlikely the use of the expired device contributed to the reported failure to seal the perforation and stent migration.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.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: 5545296
• MDR Text Key: 41787602
• Report Number: 2024168-2016-02182
• 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: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2016
• Device Catalogue Number: 1012580-26
• Device Lot Number: 4030441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 55 YR
• Patient Weight: 124